Regulatory Submission


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


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

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
  • Writing of technical dossier
  • Australian Agent Requirements
  • Handling Post Submission queries
  • OTC product registration