J. V. A. G. is involved in Preparation and Registration of Dossiers that forms the integral part of marketing Authorization of Pharmaceutical Products.
This includes CTDs, ACTDs, eCTDs etc. for Tablets, Capsules, Injections, Metered Dose Inhalers, Dry Powder Inhalers, Nebulisers, Gels and Ointments and different dosage forms.
J. V. A. G. has expertise in Preparing, Reviewing and Assessing the dossier of Pharmaceutical product 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)