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Regulatory services - Pharmaffiliates

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.<br>

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Regulatory services - Pharmaffiliates

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  1. Regulatory services BY Pharmaffiliates • DMF Filing • Dossier Preparation • Establishing Quality Systems • GMP Training • Third Party Audits • Regulatory Support Corporate Presentation2017 Pharmaffiliates

  2. DMF/ANDA SUBMISSIONS DRUG MASTER FILES (DMF) An appropriate Chemistry, Manufacturing and Control (CMC) regulatory document such as a Drug Master File (DMF) or Active Substance Master File (ASMF) that is filed by Pharmaffiliates contains the relevant details of the manufacturing process for an Active Pharmaceutical Ingredient (API) enabling competent authorities (e.g. FDA, EMA) to review process information in support of third party drug product marketing applications. Pharmaffiliates will provide a letter of authorization/access that will allow the relevant authorities to review the DMF. In addition to submitting regulatory documents in the United States and Europe, Pharmaffiliates has broad experience in filling regulatory documents throughout the world. ABBREVIATED NEW DRUG APPLICATION (ANDA) Pharmaffiliates strategic approach to successful ANDA submission focuses on gathering the appropriate ANDA information to ensure a complete application while conducting the right clinical studies. We rely on decades of experience to power bioequivalence (BE) studies and minimize study failures. This competency in clinical study design is invaluable for ANDAs that require clinical endpoint studies. Corporate Presentation2017 Pharmaffiliates

  3. CONSULTING 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 submission. Pharmaffiliates is making electronic submissions as well to the Regulatory Authorities. Corporate Presentation2017 Pharmaffiliates

  4. THIRD PARTY AUDITS Pharmaffiliates is the first Indian company to provide third party audits in India and neighboring countries on behalf of the European manufacturers in accordance with the EMEA requirements. So far we have audited above 110 companies and many others are on waiting list for the audits. Corporate Presentation2017 Pharmaffiliates

  5. GMP TRAINING Training is an area where Pharmaffiliates has made significant contribution in the Pharma Industry. It has done many open house and in-house training programs. These are well structured consisting of lectures, workshops and videos. At the end each participant is evaluated by means of a examination and the feedback is sent to management. We have conducted 52 training executives programs and trained about 3200 participants consisting of middle and senior management from Pharma Majors . Corporate Presentation2017 Pharmaffiliates

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