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.


 

News & Events


- HiGlance Laboratories entered into Cardio & Diabetic segment with the launch of "CD Care" division to cater millions of people suffering from Cardio & Diabetes diseases.

- HiGlance Laboratories is partcipating(one of the major sponsor) in RSSDI-2016 at Jhansi, UPCSI 2016 (Cardicon) at Agra, UPAPICON 2016 at Allahabad.

- HiGlance entered into liquid oral segment and already started commercial production. Our product range includes Antibiotics, Antipyretic, Anti-inflammatory, Analgesic, Ant allergy, Cough Preparations, Multivitamins etc.

- HiGlance entered in chain pharmacy segment & started catering to approx 4 million people in India.

- HiGlance Laboratories designed Calcium combination with a unique new technology called "Dispersion Technology", which ensures early absorption & faster dissolution with delicious orange flavor.
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