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8/8/2019 2010 CP Outsourcing Survey
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W E L CO M E T O O U R 6th Annual CONTRACT PHARMAOutsourcing Survey! More than 350 sponsor-side respon-dents offered up their opinions on outsourcing trends for this
years poll.
On the following pages, weve provided a sample of the find-
ings, focusing mainly on the major outsourcing projections of our
respondents, broken out by their business categories. Heres a
breakdown of the respondents:
Signs of Improvement?
Last year, a whopping 62% of total respondents believed that
theyd spend the same or less on outsourcing spending in
the coming year;this year,that dipped to 55%. Happily, the 10%+
less spending than previous year respondents dropped from
to 13%; from 23% last year, while no change increased from to
29% of all correspondents, from 25% last year.
Along those lines, 35% of respondents said that they had
cancelled outsourcing projects in the previous year due to
the economy; the same percentage as in our 2009 survey. We
added to reduce company size to our responses for Why
does your company outsource?; 7% of respondents chose
that answer, led by Top 20 Pharma, with 41% of those responses.
GYR
Photo courtesy of Fisher Clinical Services
CompanyType
Top 20 Pharma . . . . . . .23.4%
Small/Mid-Tier Pharma .18.0%
Generic Pharma . . . . . .10.1%
Virtual Pharma . . . . . . . .9.8%
Emerging Biopharma . . . .8.2%
Specialty Pharma . . . . . . .7.0%
Top 10 Biopharma . . . . . .6.3%
Consumer/ . . . . . . . . . . .3.5%
OTC Healthcare
Other . . . . . . . . . . . . . . .13.6%
Job Function
R&D . . . . . . . . . . . . . . . .21.5%
Corp. Mgmt. . . . . . . . . .13.0%
QA/QC/Validation . . . .12.3%
Project Manager . . . . . . .9.5%
Contract Manager . . . . . .6.6%
Purchasing/Sourcing . . . .5.7%
Production/Mfg./Pkg. . . . .5.7%
Business Development . .5.7%
Marketing/Sales . . . . . . . .5.4%
Clinical Research . . . . . . .4.1%
Supply Chain Manager . . .3.5%Regulatory Affairs . . . . . .2.5%
Engineering . . . . . . . . . . .1.3%
Other . . . . . . . . . . . . . . . .3.2%
ANNUAL
OUTSOURCING
SURVEY
ANNUAL
OUTSOURCING
SURVEY
The Science Of Research
At DiTEBA, we are committed to your success by providing
analytical and bioanalytical chemistry services that accelerate
R&D intensive projects.
As a pharmaceutical contract research organization, we strive
to be an innovative and cost-effective partner that delivers
consistent, quality services with unmatched integrity.
Through the science of research, let DiTEBA expedite
the process of bringing your product to market.
1620Tech Avenue, Unit 3
Mississauga, ON CanadaL4W5P4
18006719053
9056257995
9056253767
Toll Free:Phone:
Fax:
Analytical Testing
Bioanalytical Testing
Stability Storage and Testing
Cleaning Verification and
Validation Testing
Formulation DevelopmentSupport Testing
In Vitro Release Rate Testing
Physical Testing
ReaResearchTurning Research Into Re
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2010 OUTSOURCING SURVE
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2010 OUTSOURCING SURVEY
Respondents who report that their outsourcing spending
GREW in the previous year: 43.9%
WHAT DOTHEY DO?
R&D ................................................................................18.5%Corporate Management..................................................15.3%QA/QC/Validation............................................................10.5%Project Manager..............................................................10.5%
WHERE DOTHEYWORK?
Top 20 Pharma...............................................................28.2%Small/Mid-Tier Pharma...................................................16.1%Virtual Pharma................................................................14.5%Generic Pharma ...............................................................8.9%
WHATTYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................50.0%Manufacturing: Fill/Finish.................................................37.1%Methods Development / Validation..................................37.1%Process Development / Scale-Up....................................37.1%Stability Studies..............................................................36.3%Manufacturing: Solid Dosage..........................................34.7%Formulation Development...............................................33.1%
Respondents who report that their outsourcing spend
SHRANK in the previous year: 33.9%
WHAT DOTHEY DO?
R&D ................................................................................25.0QA/QC/validation ............................................................14.6Corporate Management..................................................14.6Project Manager................................................................9.4
WHERE DO THEYWORK?
Small/Mid-Tier Pharma...................................................19.8Top 20 Pharma ...............................................................16.7Generic Pharma..............................................................12.5Top 10 Biopharma.............................................................9.4
WHATTYPES OF OUTSOURCING DOTHEY MANAGE
Analytical & Testing Services ..........................................47.9Manufacturing:API..........................................................30.2QA/QC............................................................................30.2Formulation Development...............................................29.2CMC................................................................................25.0Methods Development / Validation .................................25.0Stability Studies..............................................................25.0
Past Imperfect
* Respondents can select multiple answers for this categor
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2010 OUTSOURCING SURVEY
Respondents who project that their outsourcing spending
will GROW in the next year: 44.9%
WHAT DOTHEY DO?
R&D................................................................................20.3%Corporate Management...................................................11.7%QA/QC Validation.............................................................11.7%Project Manager..............................................................10.2%
WHERE DOTHEYWORK?
Top 20 Pharma...............................................................29.7%Small/Mid-Tier Pharma...................................................16.4%Virtual Pharma................................................................12.5%Generic Pharma..............................................................10.9%
WHATTYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................49.2%Manufacturing: Fill/Finish................................................32.0%Methods Development / Validation .................................32.0%Stability Studies...............................................................31.3%Manufacturing: Clinical Trials Materials...........................28.9%CMC................................................................................28.1%Process Development / Scale-Up...................................28.1%
Respondents who project that their outsourcing spen
will SHRINK in the next year: 26.1%
WHAT DOTHEY DO?
R&D ................................................................................20.3QA/QC/validation ............................................................14.9Corporate Management..................................................13.5Project Manager..............................................................10.8
WHERE DO THEYWORK?
Top 20 Pharma...............................................................20.3Small/Mid-Tier Pharma...................................................18.9Generic Pharma..............................................................12.2Emerging Biopharma......................................................10.8
WHATTYPES OF OUTSOURCING DOTHEY MANAGE
Analytical & Testing Services..........................................41.9Formulation Development...............................................28.4Manufacturing:API ..........................................................27.0Process Development / Scale-Up....................................27.0Clinical Trials (Phase I-IV)...............................................25.7Manufacturing: Fill/Finish................................................25.7Manufacturing: Solid Dosage..........................................25.7
Future Shock
* Respondents can select multiple answers for this categor
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Of the respondents who say that their companies outsource at least 50% of their commercial manufacturing . . .
59.4% report that more than half of their outsourcing dollars go to preferred providers
78.1% report that their company have never received a warning letter due to an inspection at a CMO
51.6% either probably or definitely will not outsource a project to Asia in the next year
81.3% are would use the word partnership to describe their relations with a provider
31.7% report that they have canceled or delayed outsourcing projects in the past year, due to the economy
are most likely to work at a Virtual Pharma (32.8% of respondents), and also predominantlyoutsource more than half of clinical materials (85.2% of respondents) and APIs (88.9% of respondents)
Commercial Interruption
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2010 OUTSOURCING SURVEY
Ups and Downs
50% of all respondents said that they describe their outsourcing model asStrategic (entire classes of functions performed out-of-house), down from 55% last year.
The other 50% said they would describe their outsourcing model asTactical (case-by-case, based on availability).
Virtual Pharma companies were most likely to call their relationship Strategic (70%),
while Small/Mid-Tier Pharma was most likely to call their relationship Tactical (63%).
The largest group to say it will do 10+% more outsourcing next year
describe their companies as Top 20 Pharma, at 28%.
That was also the demographic that said it will do 10+% less outsourcing in the next year,
with 19% of the responses to that question.
8% of respondents said that their companies hadreceived a regulatory warning letter because of an inspection at a CMO;
72% said they had not and 20% were not certain.
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CONTRACTING &
OUTSOURCING 2010CONFERENCE & TABLETOP EXHIBITION
SEPTEMBER 23-24, 2010 HYATT REGENCY NEW BRUNSWICK
Sign up today! www.contractpharma.com/2010conference or www.regonline.com/cpa
Dont miss the industrys leading
Networking Conference & Tabletop Exhibition
for Pharmaceutical and Biopharmaceutical
decision-makers! Register today!
Two-day Conference: Sept. 23-24
Speakers represent FDA, large, specialty and
virtual Pharma and Biopharma, and more!
One-dayTabletop Exhibition:Sept. 23
Exhibitors include top CMOs, packagers,
distributors, CROs and suppliers!
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2010 OUTSOURCING SURVEY
THE GLOBAL SOURCE FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL
CONTRACT SERVICES AND OUTSOURCING
IN PRINT
ONLINE
WWW.CONTRACTPHARMA.CO
WEEKLY E-NEWSLETTCPDIRECT
CONTRACT PHARMA is the premier global news source dedicated to
Pharmaceutical and Biopharmaceutical outsourcing. With 10 yearly print issues,the CPDirect weekly e-newsletter, and contractpharma.com
CONTRACT PHARMA covers all the bases with the latest breaking news and editorial feature
For advertising information, please contact
Gary Durr [email protected] / 201-880-2229 or
Damaris Kope [email protected] / 201-880-2252
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Howmuchdidyouroutsourcingspending
changeinthepastyear?(byoutsourcingdecision)
Total
Analytical & Testing Services..........................................46.5%
Formulation Development...............................................28.8%
Stability Studies..............................................................28.2%
Manufacturing: Fill/Finish.................................................27.8%
Process Development / Scale-Up....................................27.8%
Methods Development / Validation..................................27.8%
Manufacturing:API ..........................................................27.5%
CMC................................................................................26.6%
Manufacturing: Solid Dosage..........................................25.9%
Clinical Trials (Phase I-IV)...............................................25.9%
R&D Services.................................................................25.3%
QA/QC............................................................................25.3%
Manufacturing: Clinical Trials Materials...........................24.7%
Chemistry........................................................................21.2%
Manufacturing: Injectable Dosage...................................21.2%
Manufacturing: Biologics, Finished Dosage....................20.3%
Drug Delivery Systems ...................................................19.9%
Packaging: Clinical..........................................................19.6
Manufacturing: Biologics, Bulk........................................19.3
Regulatory Filing.............................................................18.7
Manufacturing: Parenterals.............................................18.7
Packaging: Commercial ..................................................18.4
Validation Services..........................................................17.7
Labeling...........................................................................17.1
Supply Chain Management ............................................16.1
Preclinical / Toxicology....................................................14.6
Microbiology....................................................................13.6
Sterility Testing................................................................12.3
Manufacturing: Oral Liquid Dosage ................................12.0
Logistics...........................................................................11.4
Manufacturing: High Potency...........................................11.4
Clinical Logistics...............................................................9.2
Sales.................................................................................8.9
IT ....................................................................................5.4
Outsourcing Decisions
WHATTYPES OF O UTSOURCING DECISIONS AREYOU INVOLVED IN?*
* Respondents can select multiple answers for this catego
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WHAT DOTHEY DO?
Marketing/Sales..............................................................29.4%Project Manager..............................................................23.5%
R&D.................................................................................11.8%Business Development....................................................11.8%
WHERE DOTHEYWORK?
Top 20 Pharma................................................................41.2%Top 10 Biopharma ...........................................................17.6%Small/Mid-Tier Pharma....................................................11.8%Specialty Pharma ............................................................11.8%
WHATTYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................29.4%Clinical Trials (Phase I-IV)...............................................29.4%Sales...............................................................................29.4%CMC................................................................................23.5%Manufacturing: Biologics, Finished Dosage....................23.5%Packaging: Clinical..........................................................23.5%
Stability Studies..............................................................23.5%
HOW MUCH DIDTHEIR OUTSOURCING SPENDINGCHANGE FROM THE PREVIOUSYEAR?
10%+ less than previous year .........................................17.66-10% less than previous year .........................................5.9
Did not change ...............................................................29.4
1-5% more than previous year.........................................11.8
6-10% more than previous year........................................5.9
10%+ more than previous year.......................................29.4
HOW MUCH DO THEY EXPECTTHEIR OUTSOURCIN
SPENDINGTO CHANGE IN THE NEXTYEAR?
10%+ less than last year.................................................17.6
1-5% less than last year....................................................5.9
1-5% more than last year ................................................47.1
10%+ more than last year...............................................29.4
Reduce, Reuse, Recycle
This year, we added To reduce company size to our list of responses to the question, Why do you outsource?
Only 7.2% of that questions respondents chose that answer, so the sample set isnt much to go on.Still, heres a little info about that group.
* Respondents can select multiple answers for this catego
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WHAT DOTHEY DO?
R&D................................................................................23.5%QA/QC Validation............................................................15.1%Project Manager...............................................................11.8%Corporate Management..................................................10.1%
WHERE DOTHEYWORK?
Top 20 Pharma...............................................................24.4%Small/Mid-Tier Pharma....................................................17.6%Virtual Pharma................................................................13.4%Specialty Pharma .............................................................9.2%
WHATTYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................59.7%Stability Studies...............................................................37.0%Methods Development / Validation .................................36.1%QA/QC............................................................................33.6%Process Development / Scale-Up...................................32.8%Manufacturing: Fill/Finish.................................................31.9%R&D Services..................................................................31.9%
HOW MUCH DIDTHEIR OUTSOURCING SPENDING
CHANGE FROM THE PREVIOUSYEAR?
10%+ less than previous year.........................................16.8
6-10% less than previous year .........................................4.2
1-5% less than previous year............................................5.9Did not change................................................................21.8
1-5% more than previous year........................................14.3
6-10% more than previous year......................................14.3
10%+ more than previous year.......................................22.7
HOW MUCH DO THEY EXPECTTHEIR OUTSOURCIN
SPENDINGTO CHANGE IN THE NEXTYEAR?
10%+ less than last year ..................................................8.4
6-10% less than last year .................................................5.9
1-5% less than last year....................................................5.0
Will not change................................................................31.9
1-5% more than last year.................................................17.6
5-10% more than last year..............................................12.6
10%+ more than last year...............................................18.5
I Would Prefer To
46.5% of respondents said that more than half of their outsourcing dollars go to preferred providers.
* Respondents can select multiple answers for this category
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Specific class of APIs
Tech transfer to CMO
Analytical services
Synthesis
Alternate clinical dosage forms
Analytical testing Re-packaging and pre-clinical services
BE Studies
Phase I API manufacturing
Early phase
CMC devleopment
Contract synthesis delayed
Phase III trial and CMO production
Phase II clinical trials
Capital intensive
Clinical and IND-enabling studies
New product types or innovations
Intermediate and API synthesis
Clinical trials
Late stage product
Delayed non-priority projects
Clinical manufacturing and packaging
Nutritional
API Manufacturing
Timelines shifted Validation support
Clinical development programs
CM C
Development
Clinical trials
Small chemistry and pathology services
Preclinical and CMC
Analytics, clinical trials
Tox studies
Scale-up
Lower priority candidates
Manufacture of CTM
Clinical Trials
Delayed start of API and CTM man
turing until toxicology or clinical resu
became available. Canceled API/CT
manufacturing if toxicology or trial
results were not as expected.
Any project that went down in the litime to market or future values
Tech transfers from one CMO to ano
to consolidate our outsourced base
Discovery programs
Basic chemistry was normally out-
sourced, but a low level of projects l
doing the work in house
Preclinical
Bulk biologics manufacturing optimi
tion
Difficult synthetic projects
Specialty formulation development
Phase I & II
Why Not Outsource?
More than a third of our respondents said that theyd cancelled outsourcing projects in past year,due to the economic climate. We asked them to describe the projects they delayed.
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A PI Eary stage raw material only -
Pre-Starting material Chemistry services (5 kg, non-cGMP)
Clinical trials Bulk drug intermediates and APIs A PI Solid dosage chemical Pilot clinical study and possibly
API sourcing Bioanalytical method transfer &
validation as a feasibility exercise All projects Manufacturing Molding parts Preclinical PK studies Non-GLP CMO and release testing Currently we are already outsourcing
API and manufacturing Custom raw materials and intermediates
IT Formulation development Manufacturing for market access in Asia Intermediates development Very competitive generic
manufacturing requirements API raw material synthesis stability Formulations from India Pharmacovigilance Established product API and API intermediates to Asia
no drug product! Second line Formulation and analytical development Biologic manufacture Phase I Analytical chemistry Ones where cost is a driver Basic stability and formulation work CN S Simple, early stage only
Commercial manufacturing Lower risk projects where the cost
savings are big enough to justify the Low IP, commodity product Medicinal chemistry
Clinical trials & CMC Small Molecules Criteria has not been defined as ye Follow-on biologic Toxicology Fill/Finish Project without proprietary know-ho Exploratory work Low IP risks Non-GxP, discovery support Development projects a few steps a
from the API Only as a test Clinical trial management and disco
work Clinical supply or testing for local m Less quality critical projects
What sort of project would you be
comfortable with outsourcing to Asia?
Note: Some respondents who said they were likely to outsource projects to Asia declined to provide an example.API or some variety thereof was the most common response.
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0 25 50 75 10
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2010 OUTSOURCING SURVEY
0.00% 0.25% 0.50% 0.75% 1.00%
0.00% 0.25% 0.50% 0.75% 1.00%
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35% of respondents said that theyHAVE cancelled an outsourcing project
in the past year due to the economy
WHAT DOTHEY DO?
R&D.................................................................................27.8%Corporate Management..................................................20.3%Purchasing/Sourcing........................................................11.4%QA/QC Validation ..............................................................7.6%
WHERE DOTHEYWORK?
Small/Mid-Tier Pharma...................................................22.8%Top 20 Pharma ...............................................................19.0%Specialty Pharma ............................................................11.4%Generic Pharma..............................................................10.1%
WHATTYPES OF OUTSOURCING DO THEY MANAGE?*
Analytical & Testing Services..........................................54.4%CMC................................................................................39.2%Process Development / Scale-Up...................................38.0%R&D Services.................................................................36.7%Methods Development / Validation .................................35.4%Stability Studies..............................................................35.4%Packaging: Clinical..........................................................34.2%
65% of respondents said that theyHAVE NOT cancelled an outsourcing project
in the past year due to the economy
WHAT DOTHEY DO?
R&D ................................................................................19.0QA/QC/validation ............................................................16.3Project Manager..............................................................12.9Corporate Management..................................................12.2
WHERE DO THEYWORK?
Top 20 Pharma...............................................................23.1Small/Mid-Tier Pharma...................................................16.3Virtual Pharma................................................................12.9Generic Pharma..............................................................10.2
WHATTYPES OF OUTSOURCING DOTHEY MANAGE
Analytical & Testing Services..........................................51.0Manufacturing: Fill/Finish................................................32.0Methods Development / Validation .................................32.0Manufacturing:API..........................................................30.6Stability Studies..............................................................30.6Formulation Development...............................................29.9Process Development / Scale-Up....................................27.9
Cancellation Policy
* Respondents can select multiple answers for this categor
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HOW MUCH DIDTHEIR OUTSOURCING SPENDINGCHANGE FROM THE PREVIOUSYEAR?
10%+ less than previous year.........................................31.6%
6-10% less than previous year .........................................8.9%1-5% less than previous year............................................6.3%
Did not change................................................................13.9%
1-5% more than previous year..........................................8.9%
6-10% more than previous year........................................8.9%
10%+ more than previous year .......................................21.5%
HOW MUCH DO THEY EXPECTTHEIR OUTSOURCINSPENDINGTO CHANGE IN THE NEXTYEAR?
10%+ less than last year.................................................15.2
6-10% less than last year .................................................6.31-5% less than last year....................................................3.8
Will not change...............................................................20.3
1-5% more than last year................................................20.3
6-10% more than last year..............................................10.1
10%+ more than last year...............................................24.1
More on Cancellations
About those 35% who said they have cancelled outsourcing projects in the past year:
48.1% of them said that they outsource to focus on core competencies.
Only 8.9% said that they outsource to reduce company s
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What is your biggest complaint about
Contract Service Providers youve worked with in the past?
Heres an edited selection of what our respondents had to say.Timeliness / On-Time deliverywas the #1 complaint, with Quality issuesrunning a close second.
Misrepresentation of capabilities Asian CSPs not adhering to timelines Timeline commitments and GMP complaince on shop floor,
both with manufacturing and QA/QC
Audit scheduling Don't stick to timelines agreed upon up front Unreliable supply
Late with reports Missed protocol activities Keeping projects on schedule Reliability
Failure to deliver in a timely manner Timeliness Staff turnover
Prompt communication of problems Over-promising For some CSPs, GMP concepts and practices not "current"
with industry and regulatory trends
Faster communication and feedback. Lack of stability of employees at a CRO Cost
The cost and time at time of bid is markedly different fromthe final outcome
Lack of responsiveness Ease of doing business
Attrition and retraining Poor quality Do not take ownership of projects Product quality
Communication issues Lack of effective communication about a projects progress Poor project management
On-time delivery Not reliable Needs too much hand-holding and management Quality and yield
Overcommitment The committment Cost increases
Big gaps between claims and actual capabilitiesduring initial discussions
Conformance to tech transfer schedules and late deliveries
Over budget and longer than promised timelines Priorities driven by the almighty $ rather than relationship Poor quality and CGMP adherence Mis-communication.
Data transfer Not meeting timelines Flexibility Lack of commitment to the sponsor's needs
Not dedicating seasoned personnel to our project Lack of information sharing. Understanding flexibility needed for clinical work
Poor contingency planning Lack of open-book pricing Time to release results Increasing costs of services
Start-up is always great but close-down is alwaysa tough time
Poor communication
Internal vs. external focus Contamination issues Ability to turn work over quickly Unresponsive or minimal response to suggestions
Lack of experience in a key area that was originally statedto be a competency
Changes in project scope
Not service oriented Expectations not consistent with actual results Not being able to talk to the person doing the work Insufficent technical resources
Lack of ownership of the project Their inability to view the alliance as a partnership Communication gaps
Increasing study budgets; CRO was not willing to takeresponsibility for its own feasibilities.
Delay of the API delivery Billed for work not in the protocol
Incremental charges Schedules Quality On-time delivery
Inability to understand customer needs fully We dont have too many complaints, but with those providers
that we decided not to use again, there was
an inability to meet timelines, a lack of understandingof what it takes to get a NCE into Phase III, and weakanalytical know-how
Failure to be transparent about issues
Inability to translate provided study designs into appropriatetime and cost proposals
Under-resourced
Lack of awareness of cGMP Lack of established and reproducibile business systems Contract / agreement negotiations too long
Lack of communication Incomplete quotes Rarely take an owner's perspective Making changes without providing notification
Too hard to set up and work with each one individually Inability to say NO Slow response to inquiries (poor communication). Maintaining attention to small customer.
Higher cost / lower quality than the hype for outsourcing inIndia/China
The Science Of Research
At DiTEBA, we are committed to your success by providing
analytical and bioanalytical chemistry services that accelerate
R&D intensive projects.
As a pharmaceutical contract research organization, we strive
to be an innovative and cost-effective partner that delivers
consistent, quality services with unmatched integrity.
Through the science of research, let DiTEBA expedite
the process of bringing your product to market.
1620Tech Avenue, Unit 3
Mississauga, ON Canada
L4W5P4
18006719053
90562579959056253767
www.diteba.com
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Analytical Testing
Bioanalytical Testing
Stability Storage and Testing
Cleaning Verification and
Validation Testing
Formulation Development
Support Testing
In Vitro Release Rate Testing
Physical Testing
Rea
ResearchTurning Research Into Re
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