Integral Part of Preparation and Registration of Dossiers along with Tech Transfer

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Integral Part of Preparation and Registration of Dossiers along with Tech Transfer

Hostrin Life Sciences has been involving in Preparation and Registration of Dossiers for Pharmaceutical Products with the integral part of marketing Authorization along with facility support in all regions for the technology transfer of validation batches

This includes CTDs, ACTDs, eCTDs etc. for Tablets, Capsules, Injections, Metered Dose Inhalers, Dry Powder Inhalers, Nebulisers, Gels and Ointments and different dosage forms.

Hostrin Life Sciences has expertise in Preparing, Reviewing and Assessing the dossier of Pharmaceutical products which includes:

  • Module 1 (Administrative and prescribing information that may be region specific)
  • Module 2 (Summary of the Pharmaceutical Product)
  • Module 3 (Includes overall detailed Quality summary of the Pharmaceutical Product)
  • Module 4 (Non Clinical studies)
  • Module 5 (Clinical studies)

Hostrin Life Sciences has successfully prepared the dossiers that lead to the marketing authorization by the Regulatory Agencies of the various countries.

Hostrin Life Sciences is also into the Preparation of SPC’s, Package information leaflets (PIL) and Periodic Safety Update Reports (PSUR’s).

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