Analytical and Regulatory Support

Ultimately, successful commercialization of a regulated pharmaceutical product is directly proportional to the level of required analytical and regulatory support it receives. Here, Genzyme Pharmaceuticals stands above the competition with trained professionals who can tap into the resources of Genzyme Corporation while adhering to the highest possible regulatory standards. We offer the following analytical and regulatory services at all stages of product development:

GMP certificate
Licensed to produce and distribute APIs and pharmaceutical excipients
Licensed to do contract analysis for pharmaceutical products (raw materials, APIs, and finished dosage forms)

Independent Quality Control and Assurance

Internally audited by corporate quality organization

FDA inspected plant for API and QC laboratory

Supply chain management
Continuous optimization and improvement of the supply chain throughout the project life cycle

Full analytical services
Analytical methods

Characterization services

Stability studies

Cleaning method development and validation

Full regulatory service
Filing and maintenance of Drug Master Files (DMFs in USA, Europe, Japan, Canada, etc)

CMC quality module documentation in CTD format suitable for the submission of IND, IMPD, NDA, and MAA dossiers

Shorter time to submission by early involvement of regulatory affairs

Experienced, on-site RA team ensuring regulatory compliance

Proactive discussions of CMC development and regulatory status

The benefit of Genzyme’s experience with world-wide regulatory authorities