WE DELIVER PROFESSIONAL PROJECT MANAGEMENT … · WE DELIVER PROFESSIONAL PROJECT MANAGEMENT ......
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CONTRACT MANUFACTURING SERVICES WE DELIVER PROFESSIONAL PROJECT MANAGEMENT At each stage of our cooperaon you will be assigned a single contact person. Our approach guaran- tees proper communicaon flow which is crucial when informaon is me-sensive and accuracy is important. Evaluaon Manager will guide you through project evaluaon as well as preparaon of manufac- turing and transfer proposal. Our individual approach to each enquiry and detailed quotaons will allow you to properly esmate your budget, avoid hidden costs and keep the COGs of your product on the same level for many years. Our Project Manager will ensure that Tech Transfer of your product will go smoothly from the kick-off meeng unl product launch. You will receive transparency and all access that you need to drive your project forward on your terms. Our Project Manager will act on your behalf to ensure that your project is completed on-me and on-budget. Customer Service Manager will be in regular contact with you during order processing, commercial supply and change control implementaon. We guarantee: speed, flexibility and on-me reliability. With our Customer Service Manager on the watch, you can rest assured that the job is geng done while you do yours. Thanks to high responsiveness as well as effecve and transparent communicaon of our team, you will maintain full control over your product. TRANSPARENT ORGANIZATION FOR YOU TO MAINTAIN A FULL CONTROL POLPHARMA GROUP IN POLAND 5 manufacturing sites | 4200 employees QC & QA Tech Transfer Team Logiscs Maintenance Engineering Sourcing and Procurement Regulatory Affairs Process Engineering SINGLE POINT OF CONTACT FOR YOUR CONVENIENCE EVALUATION MANAGER STAGE 1 PROJECT EVALUATION PROPOSAL PREPARATION AND SUBMISSION CUSTOMER SERVICE MANAGER STAGE 3 ORDER PROCESSING AND COMMERCIAL SUPPLY PROJECT MANAGER STAGE 2 TECHNOLOGY TRANSFER AND PRODUCT LAUNCH CLIENT CONTACT POLPHARMA GROUP B2B Contract Manufacturing Service phone: +48 22 691 37 79 | +48 43 829 93 31 | +48 58 563 18 32 | +48 22 691 39 24 e-mail: [email protected] For more informaon please visit our website: hp://www.polpharmab2b.com Balc Sea Gdansk Starogard Gdanski Poznan Duchnice Warsaw Nowa Deba Rzeszow Cracow Katowice Sieradz Lodz Wroclaw RUSSIA LITHUANIA BELARUS GERMANY CZECH REPUBLIC UKRAINE SLOVAKIA A1 A1 A4 A4 A2 A2 S8 S8
Transcript of WE DELIVER PROFESSIONAL PROJECT MANAGEMENT … · WE DELIVER PROFESSIONAL PROJECT MANAGEMENT ......
CONTRACT MANUFACTURING SERVICES
WE DELIVER PROFESSIONAL PROJECT MANAGEMENT
At each stage of our cooperation you will be assigned a single contact person. Our approach guaran-tees proper communication flow which is crucial when information is time-sensitive and accuracy is important.
Evaluation Manager will guide you through project evaluation as well as preparation of manufac-turing and transfer proposal. Our individual approach to each enquiry and detailed quotations will allow you to properly estimate your budget, avoid hidden costs and keep the COGs of your product on the same level for many years.
Our Project Manager will ensure that Tech Transfer of your product will go smoothly from the kick-off meeting until product launch. You will receive transparency and all access that you need to drive your project forward on your terms. Our Project Manager will act on your behalf to ensure that your project is completed on-time and on-budget.
Customer Service Manager will be in regular contact with you during order processing, commercial supply and change control implementation. We guarantee: speed, flexibility and on-time reliability. With our Customer Service Manager on the watch, you can rest assured that the job is getting done while you do yours.
Thanks to high responsiveness as well as effective and transparent communication of our team, you will maintain full control over your product.
TRANSPARENT ORGANIZATION FOR YOU TO MAINTAIN A FULL CONTROL
POLPHARMA GROUP IN POLAND 5 manufacturing sites | 4200 employees
QC & QA Tech Transfer
Team
LogisticsMaintenance Engineering
Sourcing and Procurement
Regulatory Affairs
Process Engineering
SINGLE POINT OF CONTACT FOR YOUR CONVENIENCE
EVALUATIONMANAGER
STAGE 1PROJECT EVALUATION
PROPOSAL PREPARATIONAND SUBMISSION
CUSTOMER SERVICE
MANAGERSTAGE 3
ORDER PROCESSINGAND COMMERCIAL SUPPLY
PROJECTMANAGER
STAGE 2TECHNOLOGY TRANSFERAND PRODUCT LAUNCH
CLIENT
CONTACTPOLPHARMA GROUPB2B Contract Manufacturing Servicephone: +48 22 691 37 79 | +48 43 829 93 31 | +48 58 563 18 32 | +48 22 691 39 24e-mail: [email protected]
For more information please visit our website:http://www.polpharmab2b.com
Baltic Sea
Gdansk
Starogard Gdanski
PoznanDuchnice
Warsaw
Nowa Deba
RzeszowCracowKatowice
SieradzLodz
Wroclaw
RUSSIA LITHUANIA
BELARUS
GERMANY
CZECH REPUBLICUKRAINE
SLOVAKIA
A1
A1A4
A4
A2 A2
S8
S8
ABOUT USPolpharma offers 80 years of experience and expertise in drug manufacturing. As one of the top 20 generic drug manufacturers and the leader on the Polish pharmaceutical market, we provide extensive capabilities and capacity for a wide variety of solid and liquid dosage forms.
We offer customized contract manufacturing services with full analytical support in our five European cGMP-compliant production plants. We have broad experience in production of medicinal products (Rx and OTC), dietary supplements, medical devices and cosmetics.
WE DELIVER A BROAD RANGE OF CONTRACT MANUFACTURING SERVICES:
Contract manufacturing of in-bulk and finished products Packaging servicesProfessional Tech Transfer project management:
technology transferscale-up
Process validation servicesProduct Life Cycle Management - full support with product and process modificationsSerialization Service - 2019
WE PROVIDE FULL ANALYTICAL SUPPORT:Analytical Method TransferAnalytical Method Validation in accordance with ICH guidelines (physicochemical and microbiological methods)Quality control and release testing of raw materials and finished dosage forms Stability studies in different ICH storage conditions API and raw materials supplier qualification
WE ENSURE:Individual approach to each enquiry and precise calculation of product costs and Tech TransferThe highest confidentiality and IP protection standardsHighly skilled and experienced Transfer Team dedicated to your projectProfessional Customer ServiceExcellent product quality at competitive manufacturing costsQuality assurance system compliant with cGMP requirementsAccess to a global pool of trusted suppliers and a guarantee of competitive price State-of-the-art QC and R&D laboratories
Professional Project Management
5 European cGMP-compliant
manufacturing sites
Individual approach to each enquiry
POLPHARMA GROUP MANUFACTURING SITES
POLPHARMA SAPHARMACEUTICAL WORKS IN STAROGARD GDAŃSKI
Solid dosage forms, sterile infusions and injections
Specialization |
ANNUAL CAPACITY:4.3 bln units of tablets0.5 bln units of hard capsules57 mln units of glass ampoules98 mln units of Liquid Small Volume Parenteral (SVP)10 mln units of Liquid Large Volume Parenteral (LVP)
MEDANA PHARMA SA
Paediatric medicines, vitamin products and food supplements
Specialization |
ANNUAL CAPACITY:600 mln units of soft gel capsules50 mln units of non-sterile liquids9 mln units of semisolids
POLPHARMA SAMANUFACTURING BRANCH IN DUCHNICE
CefalosporinsSpecialization |
ANNUAL CAPACITY:30 mln units of tablets15 mln units of sterile powders
ANNUAL CAPACITY:50 mln units of eye drops30 mln units of nasal drops90 mln units of ampoules 20 mln units of vials2.5 mln units of pre-filled syringes
Ophthalmic and parenteral products
Specialization |
POLFA WARSZAWA
Solid dosage formsSpecialization |
POLPHARMA SAMANUFACTURING BRANCH IN NOWA DĘBA
ANNUAL CAPACITY:3 bln units of tablets 1 bln units of hard capsules
STAROGARDGDAŃSKI
DUCHNICE
WARSZAWA
SIERADZ
NOWA DĘBA
Semisolid dosage formsSolid dosage forms Liquid dosage forms Sterile injections and infusions
DOSAGE FORMS
Oral liquids• Syrups• Suspensions• Solutions• Drops
Nasal drops and gels
Eye drops• Single and multi-dosage products• Solutions • Suspensions• Products with no preservatives
Solutions and emulsions in glass ampoules
Solutions and emulsions in glass vials
LDPE Small Volumes Parenteral (BFS)
DPE Large Volumes Parenteral (BFS)
Pre-filled syringes
Topical Products and Cosmetics• Gels• Emulsions• Ointments• Shampoos• Antifungal nail polish
Tablets• Multilayer tablets• Film and sugar coated tablets• MR tablets (modified release)• IR tablets (immediate release)• Enteric-coated tablets• ODT tablets (orally disintegrating tablets)• Vaginal tablets• Effervescent tablets• Chewable tablets
Hard capsules • Filled with: powders, pellets, granulate,granulate + tablet
Soft gelatin capsules
