REGULATORY AND PHARMACOVIGILANCE

Our proficient and experienced regulatory team specializes in pharmaceuticals, herbal products, GSL, and medical device items, offering comprehensive regulatory services that align with MOHAP (Ministry of Health and Prevention) requirements. Our dedicated regulatory affairs and pharmacovigilance team provides extensive support to both our principals and clients by ensuring compliance with the latest health authority standards. Our services encompass, but are not restricted to, the following areas.

  • Registration of Pharmaceutical products, herbal products, GSL and medical device
  • Manufacturing Site registration
  • Renewal of manufacturing site registration
  • Classification of products
  • MAH registration
  • Minor variation of Registered products
  • Renewal of Registered Products
  • Handling of safety information and reporting
  • & other related regulatory services

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