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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
ACERNA Inc.
19 Bryant Road
Markham, ON
L3P 5Y7
Paul Larocque
Tel: 905-472-5747
www.Acerna.ca
Pharmaceuticals
Biologics
Medical Devices
Over-the-counterProducts
Good Manufacturing Practices
Quality Systems
Regulatory Affairs
Compliance
Training
Canada
United States
Europe
AmoSey Inc.
#719, 8-Maison Parc CourtThornhill, ON
L4J 9K5
Sharavathi Ponnuswamy
Tel: 647-624-9628Fax:289-597-1631
www.AmoSey.com
Pharmaceuticals
BiologicsVeterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
A to Z of Pharmaceutical
Industry like:Establishment/Site Licensing,
Regulatory Submissions,Regulatory/Quality Compliance,GXP, pre-approval Inspections,QA, Validation, Clinical Trials,Pharmacovigilance, Patents and
Advertising
eCTD services
Canada
United StatesEurope
Asia
India
Australia
Authentication LegalizationServices Canada
400-1390 Prince of WalesOttawa, ON
K2C 3N6
Bill Strange
Tel: 613-226-1001
1-800-336-1132Fax:613-226-7402
1-866-217-7402
www.ALSCanada.ca
Pharmaceuticals
Biologics
Veterinary DrugsMedical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
20+ years experience assistingcompanies from the
Pharmaceutical, Medical DeviceManufacturing, Cosmetic and
Animal Health Industries withDFAIT certificate authenticationand embassy legalizationservices.
Canada
United States
EuropeAsia
Africa
Australia
Latin America
mailto:[email protected]:[email protected]://www.acerna.ca/http://www.acerna.ca/mailto:[email protected]:[email protected]://www.amosey.com/http://www.amosey.com/mailto:[email protected]:[email protected]://www.alscanada.ca/http://www.alscanada.ca/http://www.alscanada.ca/mailto:[email protected]://www.amosey.com/mailto:[email protected]://www.acerna.ca/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
AxSource Consulting Inc.
336 Bronte Street South
Suite 224
Milton, ON
L9T 7W6
Ms. Navneet Sekhon
President
Tel: 905-854-6059
Cell: 416-452-0100
www.axsource.ca
Pharmaceuticals/Sterile
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
OTC
Natural Health Products
GMP,GLP,GCP & ISO
Regulatory Affairs, QA/QCClinical, Engineering,Validations incl. Software
Pre-inspection, Compliance &consultant audits
Virtual RAQA services
Canada
United States
Europe
Mexico
China
India
BNA Consultant Group
301, Dorval Av.
Dorval, Quebec
H9S 3H6
Rachid Akhiate
Tel: 514-774-1046
Fax: 514-631-3868
www.GBNAC.com
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
BNA CONSULTANTS is agroup of experts specialized inregulation of natural healthproducts, health supplements,foods and pharmaceuticals.BNA CONSULTANTS assistsnatural health product andpharmaceutical companies tofacilitate and guide themthrough the regulation
procedures.
Canada
Canadexlabs
725 Place Fortier #707
Montreal, Quebec
H4L 5B9
Mr. Fayez Chehab
Tel: 514-978-4466
Fax: 514-747-7550
www.canadexlabs.com
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Health Canada drugsubmissions: (NDS) (SNDS)(ANDS) (NC) (DIN)
Health Canada Natural Healthproducts submissions: (NPN)
Quality Control & Qualityassurance
GMP Compliance & Productregistration
Canada
United States
Europe
Gulf Arabic States(GCC countries)
mailto:[email protected]:[email protected]://www.axsource.ca/http://www.axsource.ca/mailto:[email protected]:[email protected]://www.gbnac.com/http://www.gbnac.com/mailto:[email protected]:[email protected]://www.canadexlabs.com/http://www.canadexlabs.com/http://www.canadexlabs.com/mailto:[email protected]://www.gbnac.com/mailto:[email protected]://www.axsource.ca/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Dicentra
21 Phoebe Street
Toronto, ON
M5T 1A8
Peter Wojewnik
Tel: 416-361-3400
Fax: 416-361-3304
www.dicentra.com
Natural Health ProductsCosmetics
Over-the-counterProducts
dicentra is an internationalleader in regulatory andscientific affairs within thenatural health product, dietarysupplement, food, beverage,cosmetic and OTC industries
Canada
United States
DSA Consultants
1660 North Service Road E.Units 106 & 107
Oakville, ON, Canada
L6H 7G3
Mark Moody
Tel: 905-827-0057 ext.229Fax: 905-827-0060
www.dsaconsultants.com
Pharmaceuticals
BiologicsVeterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Regulatory Affairs, Quality
Control and Quality Assurance Product Registrations,
Establishment/Site Licensing,Liaison with Health Canada,SOP Development, GMPCompliance, Audits and more.
Canada
Emergo Group
Suite 300,
1275 West 6 Avenue,
Vancouver, BC V6H 1A6
Daryl Wisdahl
Tel: 604-909-1265
Fax: 1-888-470-2695
www.emergogroup.com
Medical Devices Emergo Group helps medicaldevice and IVD manufacturersobtain regulatory approval fromHealth Canada.
Canada
United States
Europe
AsiaAfrica
Australia
Latin America
Fastrack Consulting
12 Forestgrove Drive
Ottawa, ON K2S 1V2
Dr. Kathy A. Zito
Tel: 613-286-2089
Fax: 613-831-6988
Pharmaceuticals
Biologics
Medical Devices
Extensive scientific, productdevelopment and regulatoryexperience across multipletherapeutic areas of interest
Scientific evaluation of in vitro,preclinical and chemistry andmanufacturing data
Canada
United States
Europe
mailto:[email protected]:[email protected]://www.dicentra.com/http://www.dicentra.com/mailto:[email protected]:[email protected]://www.dsaconsultants.com/http://www.dsaconsultants.com/mailto:[email protected]:[email protected]://www.emergogroup.com/http://www.emergogroup.com/mailto:[email protected]:[email protected]:[email protected]://www.emergogroup.com/mailto:[email protected]://www.dsaconsultants.com/mailto:[email protected]://www.dicentra.com/mailto:[email protected]8/11/2019 Consultants - Copy
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Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Focal Point Research Inc.
181 Lakeshore Rd. E.
Mississauga, ON
L5G 1G2
Robert Ross-Fichtner
Tel: 905-271-2709 ext. 222
Fax: 905-271-4540
www.focalpointresearch.ca
Cosmetics
Natural Health Products
Drugs
Medical Devices
Consumer Products
Packaging
Regulatory
Labeling & Marketing
Quality & Safety
Environment
Clinical
Due Diligence
Chemistry
Product Development
Canada
United States
Europe
GMD PharmaSolutions
1215 North Service Road W.
Oakville, ON
L6M 2W2
Sam Tarantino
Tel: 905-827-1300 ext. 137
www.gmdpharma.ca
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Over-the-counterProducts
Natural Health Products
Controlled Substances
Regulatory Affairs
Warehouse services
Importation
Distribution
Patient Programs
Specialty Care Pharmacy
Canada
United States
Grieb Consulting(VG Solutions)
1060 de Canna
Laval, QC
H7X 3W4
Victoria GriebTel: 450-314-3545, 514-651-0465
Fax: 450-314-3585
PharmaceuticalsMedical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Food
Regulatory affairs for cosmetics,OTC drugs, NHPs
DIN,NPN applications, Medicaldevice licenses
LiaisonHealth Canada
Regulatory training
GMP, QA/QC
Packaging review
Environmental compliances
English or French, including
translations
Canada
mailto:[email protected]:[email protected]://www.focalpointresearch.ca/http://www.focalpointresearch.ca/mailto:[email protected]:[email protected]://www.gmdpharma.ca/http://www.gmdpharma.ca/mailto:[email protected]:[email protected]:[email protected]://www.gmdpharma.ca/mailto:[email protected]://www.focalpointresearch.ca/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Integrated TherapeuticSolutions Inc.
First Canadian Place
100 King Street W. #5600,
Toronto, ON
M5X 1C9
Dimitri Fitsialos
Tel: 416-360-0393
Fax:1-866-246-1693
www.integratedTSI.com
Pharmaceuticals
Biologics
Medical Devices
Regulatory
Medical writing
Pharmacovigilence
Canadian Scientific Officerservices
Clinical development
Canada
United States
Europe
Intertek Cantox2233 Argentia Rd.,
Suite 308
Mississauga, ON
L5N 2X7
Pharmaceuticals & HealthcareTel: 905-542-2900
Fax: 905-542-1011
PharmaceuticalsBiologics
Veterinary Drugs
Medical Devices
Cosmetics
DIN Products
Natural Health Products
Specialists in toxicologyprogram design and monitoring;comprehensive regulatorystrategies; submissionpreparation and review
Scientific writing of nonclinical,clinical and CMC data
Agency interactions
CanadaUnited States
Europe
International
International Food Focus Ltd.
211 Carlton Street
East OfficeToronto, ON
M5A 2K9
Carol T. Culhane
Tel: 416-924-3266
Fax: 416-924-2726
www.foodfocus.on.ca
Natural Health Products Preparation of Health Canadapre-market submissions fornovel fibres, novel foods, foodadditives, infant formula andTemporary Marketing
Authorizations
Product license applications forNatural Health Products in foodformat
Canada
United States
Europe
mailto:[email protected]:[email protected]://www.integratedtsi.com/http://www.integratedtsi.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.foddfocus.on.ca/http://www.foddfocus.on.ca/http://www.foddfocus.on.ca/mailto:[email protected]:[email protected]://www.integratedtsi.com/mailto:[email protected]8/11/2019 Consultants - Copy
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Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
K. Friedman Consulting
537 Bedford Park Ave.
Toronto, ON
M5M 1K4
Karen Friedman
Tel: 416-783-9394
Fax: 416-783-3114
www.kfriedmanconsulting.com
Pharmaceuticals
Natural Health ProductsPreparation of natural health
product applications and sitelicense applications
Preparation of new andsupplemental new drugsubmissions, clinical trialapplications, notifiable changes
Preparation of DIN applications
Cosmetic regulatory affairs
Canada
MarcM Consulting Canada
172 Mausser Avenue
Kitchener, ON
N2M 3K7
Marcela Saad
Tel: 519-579-0821
Fax: [email protected]
www.marcmconsulting.ca
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Regulatory Strategy & MarketApplications with primary focuson the Americas
English, Portuguese, Spanishservices
Clinical trial, site license & drugapplications
GMP/GCP/ISO compliance
Post-market changes
Business development,industry-government relations
Canada
United States
Latin America
Europe
McCarthy ConsultantServices Inc.
8-1151 Gorham Street
Newmarket, ON
L3Y 8Y1
Matt McCarthy
Tel: 1-905-836-0033
Fax: 1-905-836-0006
www.mccarthyconsultant.com
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
With 29 years of experience,MCSI has evolved into anindustry leading contractRegulatory Affairs ManagementOrganization
Let MCSI be your key toregulatory compliance
Canada
United States
Europe
Asia
Australia
mailto:[email protected]:[email protected]://www.kfriedmanconsulting.com/http://www.kfriedmanconsulting.com/mailto:[email protected]:[email protected]://www.marcmconsulting.ca/http://www.marcmconsulting.ca/mailto:[email protected]:[email protected]://www.mccarthyconsultant.com/http://www.mccarthyconsultant.com/http://www.mccarthyconsultant.com/mailto:[email protected]://www.marcmconsulting.ca/mailto:[email protected]://www.kfriedmanconsulting.com/mailto:[email protected]8/11/2019 Consultants - Copy
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Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Natural Products ConsultingCorporation
39 Glen Rush Boulevard
Toronto, ON
M5N 2T6
Lionel Pasen
Tel: 905-763-9999
Fax:905-784-1110
www.npc-corp.ca
Veterinary Drugs
Over-the-counterProducts
Natural Health Products
Consultants specializing inNHPs, OTCs, cosmetics, dietarysupplements & foods
Regulatory strategy,government negotiations,product/site licensing, claimsubstantiation, GMP compliance& operations process
management
Canada
United States
Mexico
Normand RobichaudServices conseils inc.
4025 chemin Sainte-Foy
Quebec, Quebec
G1Y 1T7
Normand Robichaud
Tel: 418-650-5628
www.normandrobichaud.com
Pharmaceuticals
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Services conseils en BonnesPratiques de Fabrication (BPF)
Systmes Qualit
Audits Qualit
Conformit pour lindustriepharmaceutique, cosmtique,des biotechnologies et desproduits de sant naturels.
Canada
United States
Europe
NovaTox Inc.
10 Crane AvenueGuelph, ON
N1G 2R2
Canada
Mark Chappel
Tel: 877-680-7256Fax:519-231-0130
www.novatox.ca
Pharmaceuticals
BiologicsVeterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Specialized toxicology company
with expertise in:toxicology, safety programs
dose-response
impurities
non-clinical studydesign/interpretation
Canada
United StatesEurope
Australia
mailto:[email protected]:[email protected]://www.npc-corp.ca/http://www.npc-corp.ca/mailto:[email protected]:[email protected]://www.normandrobichaud.com/http://www.normandrobichaud.com/mailto:[email protected]:[email protected]://www.novatox.ca/http://www.novatox.ca/http://www.novatox.ca/mailto:[email protected]://www.normandrobichaud.com/mailto:[email protected]://www.npc-corp.ca/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Nucro Technics
2000 Ellesmere Rd. #16
Scarborough, ON
M1H 2W4
John C. Fanaras
Tel: 416-438-6727
Fax: 416-438-3463
www.nucro-technics.com
Pharmaceuticals
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Regulatory Affairs for cosmetics,OTCs, Drugs, NHPs
DIN, NPN, Medical Deviceapplications
Post market changes
Audits
Legal agents
Laboratory Support/pre-clinicalstudies, Genotoxicity
Canada
United States
Europe
Asia
Australia
Nutrasource Diagnostics Inc.
Suite 203
120 Research Lane
University of Guelph
Research Park,
Guleph, ON
N1G 0B4
Krista Coventry, M.Sc.
Tel: 519-341-3363
Fax: 519-341-3368
www.nutrasource.ca
Pharmaceuticals
Natural Health Products
Functional Food &Beverages
Foods
Medical Devices
Cosmetics
RA: Project Management
Concept to Claim Strategies
Applications(Pharmaceuticals/NHPs/MedDevices/Foods)
Pharmaceutical Development ofNHPs (Farm to Pharm)
Facility Compliance(GMP/SOPs)
Clinical Trial Design,Implementation, Monitoring
Canada
United States
Optuminsight (formerlyCanReg Inc.)
4 Innovation Drive
Dundas, ON
L9H 7P3
Darrell Ethell
Tel: 905-689-3980
Fax: 905-689-1465
www.optuminsight.com/srs
Pharmaceuticals
Biologics
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
One-stop global regulatorysolution for companies of allsizes and stages ofdevelopment
More than 100 in-houseconsultants and staff serveclients
Canada
United States
Europe
Asia
Africa
Australia
Latin America
mailto:[email protected]:[email protected]://www.nucro-technics.com/http://www.nucro-technics.com/mailto:[email protected]:[email protected]://www.nucro-technics.com/http://www.nucro-technics.com/mailto:[email protected]:[email protected]://www.optuminsight.com/srshttp://www.optuminsight.com/srshttp://www.optuminsight.com/srsmailto:[email protected]://www.nucro-technics.com/mailto:[email protected]://www.nucro-technics.com/mailto:[email protected]8/11/2019 Consultants - Copy
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Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Peter Jeffsand Associates Inc.
P.O. Box 73024,
RPO Legget
Kanata, ON
Canada
K2K 3C5
Peter Jeffs
Robert Jeffs
Dr. Scott Boyd
Tel: 613-839-0001
Fax:613-839-1704
www.pja-inc.com
Pharmaceuticals
Biologics
Veterinary Drugs
Peter, former director of theBureau of PharmaceuticalQuality has 30 years experienceat Health Canada
PJA, providing Chemistry andManufacturing regulatory adviceand expertise since 1996
Canada
United States
Europe
Pharmaffair Inc.
52 Sandfield Rd.
Toronto, ON
M3B 2B7
Maha Tawashi
Tel: 416-444-8090
Fax: 416-444-4246
www.pharmaffair.ca
Pharmaceuticals
Biologics
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
RA: New product submissions
Regulatory strategy
Government liaisons
Labeling and advertising
Pharmacovigilence
Product development
QA/QC
GMP
Canada
PharmEng Technology
3760 14thAvenue, Suite 201Markham, ON
L3R 3T7
Ben Lee
Tel: 905-415-3922Fax: 905-415-3966
www.pharmeng.com
Pharmaceuticals
BiologicsVeterinary Drug
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Commissioning & Qualification
ValidationQuality Systems
Regulatory Affairs
Engineering
Training
Canada
United StatesEurope
Asia
mailto:[email protected]:[email protected]://www.pja-inc.com/http://www.pja-inc.com/mailto:[email protected]:[email protected]://www.pharmaffair.ca/http://www.pharmaffair.ca/mailto:[email protected]:[email protected]://www.pharmeng.com/http://www.pharmeng.com/http://www.pharmeng.com/mailto:[email protected]://www.pharmaffair.ca/mailto:[email protected]://www.pja-inc.com/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Proficio Scientific Affairs Inc.
3700 St-Patrick
Suite 240
Montreal, Quebec
H4E 1A2
Simon Alexander
Tel: 514-296-0125
Fax: 514-933-7208
www.proficioconsult.com
Pharmaceuticals
Biologics
Veterinary Drug
Medical Devices
Over-the-counterProducts
Natural Health Products
Expert Regulatory Support for:
Clinical Trials (devices, drugs,biologics)
Product Registration
Health Authority Meetings &Negotiations
Post-market & Life-cycle
management20 years regulatory affairs &
development experience
Canada
Quality & ComplianceServices Inc.
9-6975 Meadowvale TownCentre, Suite 410
Mississauga, ON
L5N 2V7
Stephen Semple
Tel: 905-363-1182, ext.210
Fax: 905-542-7981
www.qualityandcompliance.com
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Q &C s full-time consultantsprovide complete regulatory,quality control and complianceservices for the pharmaceutical,natural health product, cosmeticand medical device industriesand their suppliers.
Canada
United States
Europe
Asia
Australia
Latin America
RaQa Consulting Inc.
7536 Bath Road
Mississauga, ON
L4T 1L2
Mia Spiegelman
Sandra Ireland
Tel:1-866-697-7272
www.raqaconsulting.ca
Medical Devices
Cosmetics
Drugs
Natural Health Products
Foods
Complete Business Solutionsand Project Management forManufacturing/Importing anddistributing Medical Devices,Cosmetics and NHPs in theCanadian market.
Canada
United States
mailto:[email protected]:[email protected]://www.proficioconsult.com/http://www.proficioconsult.com/mailto:[email protected]:[email protected]://www.qualityandcompliance.com/http://www.qualityandcompliance.com/mailto:[email protected]:[email protected]://www.raqaconsulting.ca/http://www.raqaconsulting.ca/http://www.raqaconsulting.ca/mailto:[email protected]://www.qualityandcompliance.com/mailto:[email protected]://www.proficioconsult.com/mailto:[email protected]8/11/2019 Consultants - Copy
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Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Redstone Health Group Inc.
2125 Galena Crescent
Oakville, ON
L6H 4A9
Karen Feltmate
Tel: 905-842-4230
Fax: 905-338-8970
www.rdstonehealthgroup.com
Pharmaceuticals
Over-the-counterProducts
Redstone will help you todevelop regulatory strategies forsuccessful Federal registration,Provincial listing and ultimatelydrive brand performance andbusiness growth
Canada
Regxia Inc.
5-133 The West Mall
Toronto, ON
M9C 1C2
Betty Cory
Tel: 416-620-5236
Fax: 416-620-0261
www.Regxia.com
Pharmaceuticals
Biologics
Medical Devices
Over-the-counterProducts
Regxia is a unique scientific andregulatory consulting firm with aprimary focus of collaboratingwith our customers
We provide knowledge,experience and innovation
Canada
United States
Europe
Australia
RegPharm Consulting Inc.
Montreal, Quebec
Katia Betito, Ph.D.
Tel: 514-817-4424
Pharmaceuticals
Medical Devices
Over-the-counterProducts
Natural Health Products
Cosmetics
Preparation of clinical andquality sections of regulatorysubmissions
Strategic guidance
Regulatory training
Over 15 years of experience ingeneric (parenterals) andbranded product registration
Canada
RS Consultant Services
1 Ardwold Gate
Richmond Hill, ON
L4B 2J9
Ram Srivastava
Tel: 905-918-0272
Fax: 905-237-0322
www.rsconsultantservice.com
Medical Devices
Natural Health Products
Pharmaceuticals
Biologics
Cosmetics
Pest Control Products
Consulting in Medical Devices,Natural Health Products,Pharmaceuticals, Biologics,Cosmetics and Pest ControlProducts.
Offering regulatory and qualityservices for Canada, U.S.A. and
Europe
Canada
United States
Europe
mailto:[email protected]:[email protected]:[email protected]://www.rdstonehealthgroup.com/http://www.rdstonehealthgroup.com/mailto:[email protected]:[email protected]://www.regxia.com/http://www.regxia.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.rsconsultantservices.com/http://www.rsconsultantservices.com/http://www.rsconsultantservices.com/mailto:[email protected]:[email protected]://www.regxia.com/mailto:[email protected]://www.rdstonehealthgroup.com/mailto:[email protected]:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Services PharmaceutiquesMD inc
115-B Vaudreuil
Boucherville, Qubec
J4B 1K7
Melvin Dionne
Tel: 1-866-454-8209
Fax: 450-641-2206
www.spmd.ca
Cosmetics
Over-the-counterProducts
Natural Health Products
Application pour NPN, DIN
Service dassurance qualit,cours de formation BonnesPratiques de Fabrication(BPF,GMP), demande etrenouvellement de licencedexploitation, rdaction deprocdures BPF (GMP)
Canada
SMI- Solutions
50 Alliance Blvd.
Barrie, ON
L4W 5K3
Tish Anger
Tel: 705-720-1902
Fax: 705-728-9537
www.smi-solutions.com
Medical Devices
Canada
United States
Europe
Source Nutraceutical, Inc.
11249 Clarence Avenue
Winnipeg, Manitoba
R3T 1T4
Bernie Desgagnes
Tel: 204-254-2234
Fax: 204-254-7817
www.sourcenutra.ca
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Your one-stop-solution forregulatory compliance, graphicdesign, bilingual labeling andimportation and fulfillment
services for foods, naturalhealth products, cosmetics,medical devices andpharmaceutical products.
Canada
United States
Spectrum MMC
475 Westminster Avenue
Dollard-des-Ormeaux,(Montreal) Quebec
H9G 2S3
Wayne Bryant
Tel: 514-696-0303
Fax: 514-696-0373
www.SpectrumMMC.com
Pharmaceuticals
Biologics
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
20 year track record indelivering strategic and qualityturnkey services in regulatory,scientific, clinical affairs,pharmacovigilance andmarketing to companies rangingfrom start-ups to multinationals.
Canada
United States
Europe
Asia
Australia
Latin America
mailto:[email protected]:[email protected]://www.spmd.ca/http://www.spmd.ca/mailto:[email protected]:[email protected]://www.smi-solutions.com/http://www.smi-solutions.com/mailto:[email protected]:[email protected]://www.sourcenutra.ca/http://www.sourcenutra.ca/mailto:[email protected]:[email protected]://www.spectrummmc.com/http://www.spectrummmc.com/http://www.spectrummmc.com/mailto:[email protected]://www.sourcenutra.ca/mailto:[email protected]://www.smi-solutions.com/mailto:[email protected]://www.spmd.ca/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
SPEK RegulatoryConsultants
4080 Farnsworth Cres.
Mississauga, ON
L5L 3Z3
Sunita Phull / Ella Dratewka-Kos
Tel: 647-234-4930 / 416-560-6637
Fax: 416-223-9875
www.spek-consulting.com
Pharmaceuticals
Biologics
Over-the-counterProducts
Natural Health Products
With 40+ years of combinedexperience, we provide:
Regulatory advice
Preparation of marketregistration dossiers includingpost NOC changes,Establishment/Site Licences
Regulatory support for clinicaltrial activities (Pre-submissionmeetings, CTAs,GCPinspections)
Canada
SPharm Inc.
1235, 3rdAvenue
Val-dOr, Quebec
J9P 6C3
Sabrina Turgeon
Tel: 819-824-6869
Fax: 819-824-4876
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health ProductsFood and Feeds
Product development
Regulatory affairs in NorthAmerica
Medical Writing
Submission strategy
Meeting preparation and liaisonwith Health Authorities
eCTD
Canada
United States
Europe
SpringBoard Solutions Inc.
1332 Nocturne Court
Mississauga, ON
L5H 2L8
Sheila Garven
Tel: 416-619-9025
www.springboardsolutions.ca
Pharmaceuticals
BiologicsRegulatory support in the filing
and approval of drugsubmissions
Development of position paperson regulatory policy issues
Provide affidavits and testimonyin patent cases
Canada
mailto:[email protected]:[email protected]://www.spek-consulting.com/http://www.spek-consulting.com/mailto:svaralo@spharm./cahttp://www.spharm.ca/mailto:[email protected]:[email protected]://www.springboardsolutions.ca/http://www.springboardsolutions.ca/http://www.springboardsolutions.ca/mailto:[email protected]://www.spharm.ca/mailto:svaralo@spharm./cahttp://www.spek-consulting.com/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
Stan North Consultation
4611 Harvard Ave.
Montreal, Quebec
H4A 2X3
Stan North, M.Sc.
Tel: 514-577-5913
www.StanNorthConsultation.com
Pharmaceuticals
Biologics
Medical Devices
Over-the-counterProducts
Natural Health Products
Cosmetics
Regulatory consulting for thepharma, medical device andbiotech sectors
Clinical and CMC submissions
CTAs
Project management
Product monographs andlabeling
Regulatory guidance andstrategy
We offer quality service,flexibility and customer-focuswith over 16 years of industryexperience
Canada
SYLLA CONSEILS INC.
2149 Lincourt
Longueuil, Quebec
J4N 1N8
Sylvie Lachance
Tel: 450-332-0928
Cell:514-823-0928
Fax:450-332-0928
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
Over-the-counterProducts
Natural Health Products
Regulatory Affairs
DIN,NPN applications & Medicaldevice licences
Establishment/Site Licensing
QC/QA implementation & follow-up
GMPs, GLPs,SOPs training
Internal & External Audits
Liaison with Health Canada &FDA during inspection
Packaging review
Canada
United States
Europe
mailto:[email protected]:[email protected]://www.stannorthconsultation.com/http://www.stannorthconsultation.com/mailto:[email protected]:[email protected]://www.syllaconseils.com/http://www.syllaconseils.com/http://www.syllaconseils.com/mailto:[email protected]://www.stannorthconsultation.com/mailto:[email protected]8/11/2019 Consultants - Copy
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2013 List of Consultants (see Disclaimer)
Company Name / Address Contact InformationSummary of Services (see Notes)
Product Areas: Services: Countries:
THT Health Communications
15 Woodend Drive
Carlisle, ON
L0R 1H2
Tracy Howard-Tripp, M.Sc.
Tel: 905-690-9746
Fax: 905-690-9665
tracy.howardtripp@sympatico.cawww.medicalregulatoryconsulting.com
Pharmaceuticals
BiologicsStrategic RA expertise in pre-
market and post-marketapplications
Specialized medical writingproficiency in preparation ofdocuments for productdevelopment (i.e. clinical trialprotocols, IBs, CSRs, PMs and
clinical summaries
Canada
W. Harvey Regulatory and
Writing Service, Inc.
18 Windham Trail
Aurora, ON
L4G 5M3
William Harvey
Tel: 905-713-0920
Pharmaceuticals
BiologicsRegulatory submissions for
clinical trial and marketingapplications including chemistryand manufacturing,pharmacovigilance andestablishment licenses.
Preparation of briefingdocuments, submissionsummaries, clinical studyprotocols and reports
Canada
mailto:[email protected]:[email protected]://www.medicalregulatoryconsulting.com/http://www.medicalregulatoryconsulting.com/mailto:[email protected]:[email protected]:[email protected]://www.medicalregulatoryconsulting.com/mailto:[email protected]8/11/2019 Consultants - Copy
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List of Consultants
The list comprises consulting companies whose primary focus is Regulatory Affairs, Clinical Research, Quality Control or Compliance (GCP, GLP, GMP) forpharmaceuticals, biologics, veterinary drugs, medical devices, cosmetics, over-the-counter products, or natural health products. Companies are listedalphabetically by company name.
List of Acronyms:
DIN = Drug Identification Number
DMF = Drug Master File
GCP = Good Clinical Practice
GLP = Good Laboratory Practice
GMP = Good Manufacturing PracticesNHP = Natural Health Product
QA = Quality Assurance
QC = Quality Control
RA = Regulatory Affairs
SOP = Standard Operating Procedures
Notes:
Clinical Trials Research includes conduct of trials (Phases I-IV), bioanalytical, data management and statistical services.
GCP includes guidance on requirements, preparation of SOPs, conduct of audits and GCP training.
GLP includes guidance on requirements, preparation of SOPs, conduct of audits and GLP training.
GMP includes guidance on requirements, preparation of SOPs, conduct of audits and GMP training.
Product Development includes guidance on requirements for moving through the therapeutic product development process.
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Quality Assurance/Quality Control (QA/QC) includes arranging appropriate product testing and release.
Regulatory Affairs (RA) comprises review, assessment and preparation of appropriate regulatory documentation. Expertise in Clinical and/or Quality
(chemistry and manufacturing) aspects is specified.Toxicology includes nonclinical drug development and safety programs.
Disclaimer:
CAPRA / ACPR maintains this List of Consultants as a service to industry and to the regulatory authorities. The individual companies have provided theinformation on the list for presentation in a standard format. CAPRA / ACPR does not endorse any of the consultants on the list.
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