PPC specializes in compilation of Drug master file for pharmaceutical products which have an official monograph in European Pharmacopeia. CEP (Certificate of Suitability) is provided by EDQM to certify that the product complies with requirement specified in the official European Monograph.
PPC provides following services with regards to CEP
Compilation of DMF , with regards to CEP Requirement
Writing of Entire CEP
Review of CEP Application
Technical Advice and Meeting to meet CEP Requirement
Conversion of paper application to Electronic format
Compile, Review, Submit , Post submission queries and Final Registration of CEP
Renewal of CEP Applications
USA – US FDA
US Drug Registration & Drug Listing
US FDA requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. . (Source www.FDA.gov)
PPC helps manufacturers and any other business which is engaged in above activity to register their establishment and list their drugs/ products with US FDA.
Service Provided by PPC in this regards
Drug Establishment Registration for – API Manufacturers, Drug Intermediates, OTC products, Vetinary products
Drug Listing Submissions for API Manufacturers, Drug Intermediates, OTC products, Vetinary products
Medical Device Registration for Export to US
Medical Device Facility Registration with US FDA
Food Facility Registration with US FDA
US FDA & Health Canada
Annual Reports & Amendments to US Drug Master Files & Health Canada
US DMF holders are required to submit ANNUAL Reports for their submission to keep their submission in Active Mode.
PPC Help Companies comply with such requirement by assisting them with
Filling Annual Reports for DMF holders to US FDA Annually on their behalf. ( Type I , II, III , IV & V)
Amending Existing DMFs ( Type I , II, III , IV & V)
Re Activating In-active US DMFs.
US Agent requirement for FDA Purpose.
Compilation and Submission of DMFs for Health Canada Sub
Australia – ARTG – Australian Registrar of Therapeutic Goods
ARTG follows 2 tier systems where
High Risk Medicines are required to be registered with ARTG Involving evaluating , safety, quality, and effectiveness of the product
Lower risk Medicines containing pre-approved, low risk ingredients, making limited claims can be listed with ARTG involving assessment of safety and quality of the product.
PPC assist Pharmaceutical and Packaging Manufacturers to register and list their products with ARTG.
Compiling Application of Submission for both High Risk & low Risk Medicines
Compiling required technical dossier for submission
