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Fine Chemicals Corporation Home Contact



 


Regulatory Affairs

Fine Chemicals Corporation strives to meet requirements of Regulatory Authorities worldwide to ensure granting of Marketing Authorization Approvals to support customer marketing intentions. In consultation with the customer, Fine Chemicals Corporation will provide regulatory support in the form of a Certificate of Suitability (COS/CEP) or an Active Pharmaceutical Ingredient Drug Master File (DMF) in US or CTD format.

Regulatory personnel have experience and expertise in:

  • Marketing Authorisation procedures in the Americas, EMEA and APAC countries
  • Applications for successful Certification for active pharmaceutical ingredients (COS/CEP)
  • Compilation of Drug Master Files in various formats
  • Variation procedures

Fine Chemicals Corporation currently has an intellectual property portfolio of in excess of 150 DMF submissions in 16 countries worldwide.

The Regulatory Affairs Department further ensures that FCC operates in compliance with regulatory commitments contained in submissions such as Drug Master Files and Certificates of Suitability.

 


Quality Control

The Quality Control Laboratory function complies fully with cGMPs and is capable of performing virtually all testing in support of the product range.... read more

Environment and Safety

FCC has in place appropriate Occupational Health, Safety and Environmental (OHSE) policies. The company employs a full time Risk / Loss Control Manager who...read more