The KPSCS Regulatory Affairs team has significant global experience in drug development and establishment of regulatory stratigies. This endows our clients to develop their new drugs more efficiently and to accomplish timely and successful regulatory submissions.KPSCS is an association of regulatory affairs consultants, providing consultancy to Pharmaceutical and Active Pharmaceutical Ingredients (API) industries. KPSCS expertises in development of Dossiers, Drug Master File (DMF), and Common Technical Document (CTD). KPSCS provides regulatory affairs consultancy tailored to meet client’s specific needs. Client’s data security and confidentiality is assured to the highest level.
We provide services from submission to final approval at the office of DCG(I), FDA Bhawan, New Delhi. We facilitate the guidelines for getting approval / N.O.C. for following applications:
Regulatory services for New Drug Approvals,Import Registration, & getting N.O.C.
On Stability Study
Bulk Drugs
Form-10
On Bioequivalence Study
Finished Formulations
Import,Export
On Clinical Trial Study
Medical Devices
Test License
On Toxicity Study
Vaccines
Neutral Code
We have tie-ups with well established laboratories to carry out analytical testing (HPLC,LC-MS, GC-MS,IR,UV,X Ray Diftraction,DSC,NMR).
In short, we serve the entire spectrum of regulatory needs for our clients, based on experience and knowledge.
If you are a Study Sponsor, and you are interested in contacting us about a current or upcoming project or if you require any other assistance, please contact at : 91-120-4231720/21, 91-9873038019 / Email: contact@kpsclin.com
Website: www.kpsclin.com
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