Services

Identifying right partner to source APIs / Intermediates for our International customers

We are engaged in to API sourcing and marketing for all our partners worldwide in the International markets backed by Regulatory requirements such as GMP and DMF.

Contract manufacturing (CRAMS)

We identify the right manufacturing company for contract manufacturing on long term basis. Confidentiality of the products and the pricing will be maintained

Regulatory services

Compilation of an original submission
To file DMFs, ASMFs and CEP’s / COS
Product Registration Submissions like IND/NDA /NDS/ANDAs/AND/Other Dossiers in USA,EU,Canada, ROW Countries, etc.
Application can be in CTD, aCTD, NeeS and eCTD Formats
Life Cycle Management of submitted applicationS, i.e., Post approval maintance like PAS, CBE 30/CBE, Annual Reports to US, Varitions to EU
SPL Submisstion of finished formulation – NDC labels submitted with FDA through SPL
Converting from papper to eCTD
Establishment registration, self-identification, ESG Gateway Account creation