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- Finished Product Development including Preparation and Submission of Dossiers
- Drug substance, development and supply
- Regulatory Affairs Consultancy
- Support customers with electronic reporting of ADR
- Post-authorisation regulatory, Qualified Person and Pharmacovigilance support
- Organisational support
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Jenson is developing pharmaceutical products. in partnership with reputable manufacturers and we are offering:
- Supply of finished dosage form with or without regulatory service including management of bioequivalence testing and clinical trials
- Supply of dossiers for finished dosage form products with or without regulatory support
- Development and supply of API through to development and supply of finished dosage form product
We also can help with
– Developing products designed for regulatory success.
– Contract (Toll) Manufacturing
– Exclusive development contracts for individual customers from API to finished dossier form
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We will work with our Principals to provide the following for our Customers:-
- Market and patent evaluation
- Sourcing and supply of generic APIs
- Preparation of Drug Master Files (DMF)
- Preparation of applications for European Certificate of Suitability (CEP)
- Full GMP audit of API facility
- Pre and Post Health Authority Facility Inspection Support
- Development of generic APIs
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