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Perfect Pharmaceutical Consultants Private Limited

Pimpri Colony, Pune, Maharashtra

| GST  27AAECP3623M1Z7

is a member of IndiaMART

| Verified Supplier

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Pharma Regulatory Services

Our range of services include Pharma Regulatory Service, Europe Pharmaceuticals Service, Clinical Trial Services, Biopharmaceutical Services and Bioequivalence Study.

Pharma Regulatory Service
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Catering to the diversified needs and necessities of our esteemed customers, we are engaged in unbeatable quality Pharma Regulatory Service. Rendered by one of the most qualified personnel, our offered services are highly acknowledged for their on-time delivery, promptness and reliability. Besides this, we assure delivering them to our customers’ at most reasonable rates.

Specifications:

  • CTD and ECTD submissions on all types of drug products
  • US and Canadian Drug Master file(DMF) for API, Excipients, Packaging Materials
  • Certificate of Suitability as per EP (CEP)
  • Summary of Product Characteristics (SmPC)
  • Periodic Safety Updates (PSUR)
  • New Drug Application(NDA), Investigational New Drug Application(IND)Abbreviated New Drug application (NDA)

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Europe Pharmaceuticals Service
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Aided by a team of skilled and highly knowledgeable personnel, we are engaged in presenting Europe Pharmaceuticals Service to the market at most reasonable rates. While rendering these services to our customers, our professionals utilize exceptional quality tools and machinery to maintain the flawlessness of our offered range of services.

Specifications
:

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

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Perfect Pharmaceutical Consultants Private LimitedG-4 & 5, Prestige Classic Building, D Wing Dawabazar, Opposite Kanitkars Hospital, Pimpri Colony, Pune-411019, Maharashtra, India

Sumit R. Gupta (Director)

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