Successful FDA Inspection at UK Center of Excellence
March 16, 2020
MedPharm, the leading global contract development organisation for topical and transdermal products, has successfully completed a general and pre-approval inspection by the FDA at its facility in Guildford, UK.
The inspection took place between March 2nd and 6th. The FDA inspectors found the Guildford site and the ANDA submission support activities on behalf of their client to be compliant and no Form 483 observations were issued.
This follows on from the recent successful pre-approval inspection by the FDA at the company’s Durham, NC facility.
‘This second successful site inspection by the FDA within a 3-month period is a direct reflection of the innovation and quality inherent throughout MedPharm’s global operations and is a strong endorsement of the integrity and diligence of our scientific teams,’ commented Eugene Ciolfi, MedPharm’s President and CEO.’
‘This underlines the quality systems of our units and the sophisticated and proprietary in vitro models MedPharm has developed to de-risk client’s developmental programs’.
Both inspections were unannounced and were triggered by data generated by MedPharm’s clients abbreviated new drug applications (ANDA) for generic topical products. The ANDA submissions used MedPharm’s in vitro models to demonstrate the bioequivalence of the new generic to the originator in line with the new FDA guidelines.
MedPharm is the world’s leading contract provider of topical and transdermal product design and formulation development services. MedPharm is experts at reducing risk and accelerating development times for generic and proprietary pharmaceutical customers through their unique, cost-effective and industry-leading performance testing models. Well established as the global leaders in dermatology, nail, mucosal membrane, and transdermal product development, MedPharm can also offer innovative solutions for ophthalmic and airway preparations recognised for their scientific rigour by regulators and investors. MedPharm has fully established Centers of Excellence in the USA and the UK.