Pharmaceuticals - Bhubaneswar, Odisha, India
With an evident and profound base of writing, reviewing and editing the scientific communications, Reseapro launched its new service vertical RESEAPROPHARMA. It provides clinical regulatory writing, Pharmacovigilance support, and regulatory consultations to Pharmaceutical, medical device and allied life science industries. The writing and reviewing documents includes inter alia Investigator Boucher and updates, Clinical trial protocol, Informed consent document,Reseapropharma powered with 21 CFR (Part 11) and Eudra Vigilance compliant pharmacovigilance database to carryout pharmacovigilance activity. Our articulate exponents are proficient in writing aggregate reports like PSUR, DSUR, PADER etc. Reseapropharma takes up Regulatory consultation, dossier preparation and submission assignments from pharmaceutical majors. We provide complete tactic and strategic service to leading CROs and sponsors. We provide consulting and documentary support for DSIR, CDSCO, State FDA, GLP, FSSAI, NABL approval. We support in preparing and reviewing of regulatory labeling documents (CDS, USPI, SmPC, LPDs). We write patient information leaflet, CTD all modules and DMF all types.