PERFECT CONSULTANTS (PC) - Regulatory Affairs Consulting
PC is an association of regulatory affairs consultants, providing regulatory affairs consultancy to Pharmaceutical and Active Pharma Ingredients (API) industries. PC mission is to solve the regulatory puzzle for companies, so that they can comply with the latest regulatory norms in minimum possible time, thus saving both time and resources of the client.
PC expertises in development of Dossiers, Drug Master File (DMF), and Common Technical Document (CTD).We have developed dossiers for more than 100 pharmaceutical companies which were registered in more than 20 countries.
PC provides tailored regulatory affairs consultancy to meet client’s specific needs. Client’s data security and confidentiality is assured to the highest level.
We also provide related database on CD-Rom, Master Validation Program, GMP, Stability Studies etc for pharmaceutical industry.
We have tie-ups with well established lab (NABL Certified) to carry out analytical testing (HPLC,LC-MS, GC-MS,IR,UV,X Ray Diftraction,DSC,NMR).
We also have active association with EU/US approved study centers with state of art facilities to perform BA/BE studies as well as Phase I, II, & III clinical studies.
Perfect Consultants aims is to help clients access the export market in shortest possible time, by being their Perfect Regulatory Affairs Partner.
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1) Regulatory Affairs Outsourcing in Pharmaceutical
Regulatory Affairs Unit in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully. Today a Regulatory Affairs department is a dynamic business unit which works with a focus to get products to the market with a commercially viable label in the least possible time and expenses.
Today the world has become a global village and many companies are in a race to place many new products in the world markets to gain market share and increase earnings. In such a scenario a small delay in gaining market access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators. So to obtain timely marketing approval companies can either strengthen then regulatory department or outsource the same to regulatory affairs consulting firm .....Regulatory Affairs-Outsourcing