Dossier Development

Pharmaffiliates Analytics & Synthetics (P) Ltd, is engaged in Dossier Development for highly regulated markets like US, EU, Australia, New Zealand, South Africa, Brazil, Mexico and emerging market like Commonwealth of Independent States (CIS countries), Latin America and MENA Countries (Middle East and North Africa)

We are also involved in Preparation and Submission of DMF and CoS, Submission for EU as per EDQM, UK as per MHRA, Australia as per TGA, South Africa as per MCC, Brazil as per ANVISA and CIS Registration besides compilation of dossiers in CTD Format.

Advantage Pharmaffiliates

  • Compliance with Global Quality Standards.

  • Commitment to Quality and Timely deliverance.

  • Qualified and Competitive team.

  • Quality at a Reasonable cost.

  • Ready to face audits by worldwide Regulatory authorities.

  • First Indian company to perform audits for European customers in accordance with EMEA requirements.

  • Our 2500 Impurities synthesized

  • Our 300 Methods Developed & validated

  • State of the Art Facilities

  • Working for European and US customers
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