Regulatory Affairs for Pharma and Biotech

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For the pharmaceutical and biotech industries, regulation criteria is crucial because it makes sure that products are developed and sold in accordance with regulatory requirements. Whether it comes to conventional pharmaceuticals, generics, vaccines, biologicals, biosimilars, or Advanced Therapy Medicinal Products, the MedWatch Global Group provides the entire services, handling quality management and supporting the complete drug regulatory lifecycle.

UTILIZE OUR EXPERTIES TO UNLOCK REGLATORY SUCCESS

i) Regulatory approach
  • Uses for clinical studies (CTA, IB, IMPD, etc.)
  • Expedited process (PIP, ODD, etc.)
  • Regulatory filings (MAA, eCTD, NeeS, etc.)
  • Lead for programme and project administration
  • Filing and licencing approach
  • Interpreting legislation
  • Document Gap analysis and due diligence
  • Calculating authority costs
  • Technical guidance
ii) Regulatory and Research Writing
  • Preparing submittal documents (eCTD)
  • Gap analysis and revisions to the execution instructions as per regulatory requirements
  • Enter information into clinicaltrials.gov(FDA)
  • Putting raw data into papers that comply with regulations through technical writing
iii) Post-Market Regulatory Concerns for nutraceutical / Herbal / Homeopathy and Pharma
  • Safety following clearance
  • Variants and renewals
  • product evaluation