Regulatory Affairs
Regulatory department of HiGlance is vital and ensures that its organization complies with all of the regulations and laws pertaining to Pharmaceutical Products. This department works with all regulatory agencies on issues affecting Pharmaceutical Products.
- Regulatory department look after development of Dossiers, Drug Master File (DMF), and Common Technical Document (CTD) for registration process of medicinal products to Drug Registration Agency; obtaining of marketing authorization
- Preparation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of Drug Registration Agency (including Braille)
- Variations - submission and monitoring
- Renewals of marketing authorizations
- Transfer of marketing authorizations
- e-Submission Management including reformatting from CTD to eCTD
- User Testing (Readability Testing) of PIL; preparation, testing, translation and report submission
- The regulatory procedures involved in clinical research.
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