REGULATORY AND QUALITY
Regulatory / Our Certification History:
- 1989: Clinical trials for an estradiol drug in adhesive patch
- 1992: Building of a dedicated facility to manufacture transdermal systems
- 1994: AFSSASPS agreement for human medicines (BPF, French equivalent to cGMP)
launch of Oesclim® (estradiol Hormone Replacement Therapy patch) in the European market with Mutual Recognition Procedure (MRP) registration (20 countries)
valid for both matrix and reservoir patches - 1998: FDA agreement for human medicines (cGMP)
launch of Oesclim® in the US and Canadian markets
valid for both matrix and reservoir patches - 2010: Target the ISO 13 485 certification by LNE/G-MED for Medical Devices for the end of 2010
Quality
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We offer a full service laboratory able to test all types of drugs’ forms with both general equipment and equipment specific to Transdermal Delivery Systems. Our large analytical laboratory offers a comprehensive package (QA & QC testing) for both contract manufacturing and contract development purposes: |
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Our laboratory is equipped with the most recent machinery and information system to ensure our clients fast and reproducible results in a cost-effective manner.
EVENTS
