Pharma Export/Import Registration

We have hand on experience of product registration for export market across the world. We have more than 1200 CTD dossiers ready along with drug master file, analytical method validation and comparative dissolution profile. We are capable to compile CTD dossier within a day.

If you are planning to enter into Pharma export then you should have ready CTD dossier list with you to make a deal. Noteworthy you should have trustworthy outsourcing partner who can handle query reply of any FDA within the timeline and in a proper way. Our expert team can give you CTD dossier and its query reply on time without follow ups.

We  offer  guidance  throughout  the  entire  process,  from  product  selection  and buyer  selection  to  country  selection. Our expertise extends to providing insights into multiple export strategies, ensuring a fast track return on investment (ROI).

Drug Regulatory

We can compile a CTD dossier within a day, provided you have the necessary documents ready for compilation. Our Drug Regulatory Services encompass e-CTD & CTD dossier compilation and filing, ACTD & Vet dossier as well as comparative Dissolution and Analytical Method Validation. Additionally, we conduct Gap analysis of drug master file and drug product dossier. Timely responses are crucial to us.

Drug Safety

Drug Quality and Drug Safety go hand in hand. We are providing end to end drug safety services from establishment of drug safety department to operational activities, audits and inspections. Acting as an extension of your team, we confidently handle conducted by national and international health authorities. Independently managing all aspects, we address submissions and respond to queries, both pre and post marketing authorization.


We  can  provide  a  competitive  offer  for  services,  including  Bioequivalence  Study,  Preclinical Study, Clinical  Study,  Determination  of  Permitted  daily  exposure  (PDE)  Value  of  API.  Our offerings that align   with   your   budget   and   hold   approvals   compliant   with various regulatory standards such as USFDA, MHRA, EMA, CDSCO etc.

We will handle your complete projects starting from selection of CRO, price negotiations, protocol clearance from CDSCO, analysis of quality of studies.

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