DPSE consultancy founded in Year 2012, by Clinical and Regulatory Professional Mrs. Neelprabha Rathore who have been associated with some of the known pharmaceutical companies for close to a decade now.

DSPE Consultancy provides end to end regulatory services starting from gap analysis of the dossier, product development guidance, regulatory strategy, scientific writing of dossier, submission to health authority, query response and approval. Our services cover APIs and Formulations for RoW and Emerging Markets as well. We have supported our clients to obtain successful regulatory approvals of their APIs and/or Finished Products across the globe viz., EU, CDE-China, ROW, CIS, African and Asian Countries. We have prepared more than 400 PDE/OEL reports for our clients involving pharmaceutical companies and CMOs. The DMF, Dossiers, Clinical and Nonclinical overviews and Written & Tabulated summaries either literature based or Sponsor’s study reports have helped our clients to obtain the Marketing Authorizations for their Generic, Well-established use or Novel molecules. Our templates are regulatory compliant and may be customized based on Sponsor’s suggestion/recommendation.