Regulatory

Pharmaffiliates has a strong Regulatory group. Advisors from Europe and US are also on board to have specific advice. The group has a good client list and has many US and European approvals to their credit.

We prepare Dossiers and ANDA in CTD format with a proactive thinking to avoid the deficiencies in the same. Pharmaffiliates is making Electronic submissions as well with the Regulatory Authorities.

Pharmaffiliates is the first Indian company to provide Third party audits in India and neighbouring countries on behalf of the European manufacturers in accordance with the EMEA requirements. So far we have audited fourteen companies and another group of eight awaits audit.

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  500 Impurities Synthesze


  • Our 200 Methods Developed & validated


  • State of the Art Facilities


  • Working for European and US cumtomers
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