PHARMA REGULATORY CONSULTANCY

I can provide assistance and guidance on a wide range of research topics. Whether you need help formulating research questions, designing a research methodology, finding relevant literature, or analyzing data, feel free to ask specific questions or provide more details about your research project. I will do my best to assist you in the following areas.

  • General toxicity, genotoxicity, cytotoxicity, radiotoxicity, and carcinogenicity protocol designing.
  • Preclinical invivo and invitro experimental studies. Screening extract or isolated phytocompounds for potential therapeutic ability.  
  • Phytochemical and pharmacological screening, evaluation, formulation, sand standardization of natural product-based formulations for preclinical safety (acute, sub-acute, and chronic dosing related) and efficacy.
  • Laboratory facility and Animal house development.
  • Toxicological studies of APIs, oral and IV formulations for regulatory approval of DCGI, MHRA, USFDA, Nordic, Gulf, South Asian, and REC countries.
  • Toxicological study protocol development, animal dose calculation, dose range selection with justification (PED, MTD, HED, NOEL, and MRHD), study parameter selection for oral, IV, IM, and eye sensitivity studies.
  • PSUR and CTD non-clinical overview generation with extensive literature review for DCGI and MHRA.
  • Non-clinical pharmacological study reports, Clinical efficacy, and Clinical safety documents.
  • Patent documentation and tracking of application.