Regulatory Submissions

PSC has consultants with extensive regulatory submission experience, who could assist you in

• BLA, NDA, ANDA, PMA and 510k

PSC can advice you on the requirement and formats of Biological License Application (BLA), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Premarket Approval (PMA) and Premarket Notification (510k) documents. We can help you prepare, assemble and review the required documents and reports. At PSC, we know how important it is to you to expedite the FDA review and get your product to the market faster. We strive to maintain a relationship of mutual trust and respect with regulatory agency personnel, and to develop a pattern of proactive communication with agencies to promote timely decision-making and progress towards completion. With our continued positive interactions with regulatory agencies, we can help you achieve your goals faster.

 

• Drug Master File (DMF)/ Active Substance Master File (ASMF)

We can help you to • File Letters of Authorization •Maintain Customer List •Create DMF/ ASMF • Update your active substance Annually to DMF/ASMF. You will be relieved of the complexities of Investigational New Drug Applications (IND), NDA, ANDA, Export Application, or amendments and supplements to any of these while your DMF/ASMF is under our care.

 

• Chemistry, Manufacturing and Controls (CMC) related submission

We can help you prepare, assemble and review the required documentation and reports tailored to suit the substance submitted for IND, NDAs, ANDAs and Annual reports. We can also handle CMC-related queries from US and international health authorities and coordinate and participate in meetings with relevant authorities to resolve scientific technical or regulatory issues resulting from a review of submission or compliance action.