A M P S I  is leading Pharmaceutical  Solutions Provider company. The majority of our  Pharmaceutical Solutions are On site Client solutions (cGMP, cGLP, Method testing, developing, validating, writing site plans) Clinical Research & Clinical Statistical consultation (expert Ph.D Statisticians) Medical Writing & CROs Writing SOPs, Protocols, Reports & Reviews Regulatory Affairs Designing & Developing Diagnostics kits and tools (PCR based, ELISA, Western Blots)

Drug Development

• Evaluate/ assess clinical potential of new products.
• Develop the Drug Development strategy.
• Participate in various Product Launch meetings.
• Identify and recruit Medical and Scientific consultants

Clinical Research

• Provide consultation in the Planning phase of various clinical trials.
• Review & evaluate study proposals, including protocols, and study designs.
• Provide consultation in the recruitment of CROs and Principal Investigators.
• Participate in Investigator’s meetings.
• Review clinical study reports, abstracts & manuscripts for medical and scientific integrity. Prepare clinical reports.
• Supervise CRAs
• Conduct GCP on-site clinical audits.
• Conversant with statistical interpretations of clinical trial results.

Medical Affairs

• Marketing Functions:
  ·  Provide Medical support to Marketing programs.
  ·  Review promotional and art work (package insert, Product Monographs, CPS galleys) for medical integrity.
   
• Sales Medical Training:
  ·  Conduct Medical Training (disease and product) targeted for Sales Representatives and staff.
  ·  Assist in the preparation of training manuals and Patient Education materials.
   
• Adverse Drug Reaction Reporting:
  ·  Assist in the reporting of Adverse Drug Reactions. Assess causality on the ADRs.
  ·  Liaise with the Bureau of Drug Surveillance.
  ·  Manage corporate Drug Safety Database.
   
• Medical Information Support:
  ·  Provide support on product information calls.
   
• Executive Summaries/SOPs:
  ·  Review medical data from clinical trials & prepare executive medical summaries.
  ·  Assist in the preparation of various SOPs for medical/clinical department.
   
• Regulatory Affairs:
  ·  Review regulatory submissions (INDs, NDSs, SNDs) for medical integrity.
  ·  Experience with TPP Level I/II Appeal processes.
  ·  Supervise and Manage Special Access Program