Dossier Services

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)

J. V. A. G. till today has successfully prepared the dossiers that lead to the marketing authorization by the Regulatory Agencies of the various countries.

J. V. A. G. is also into the Preparation of SPC’s, Package information leaflets (PIL), Periodic Safety Update Reports (PSUR’s).

DMF’s Preparation, Registration and Filing

We help in Scientific Writing of Drug master files (confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging and storing of one or more human drugs) for the Active Pharmaceutical Ingredients.

J. V. A. G. provide different types of DMF with latest updation and country specific format.

  • Type II : Drug Substance, Drug Substance Intermediate, and Material Used in the Preparation of Drug Product
  • Type III : Packaging Material
  • Type IV : Excipient, Colorant, Flavor etc.
  • Type V : FDA Accepted Reference Information
  • Compilation of Open and Closed parts of DMF’s

J. V. A. G. collaborates with different renowned laboratories to provide with Analytical Studies, Validation, Elemental Analysis, Stability etc. for the active ingredients as well as pharmaceutical products

Clinical and Nonclinical support

J. V. A. G. has expertise in Documentation of Nonclinical (Module 4) and
Clinical (Module 5)

  • Literature Research
  • Preclinical Experts Reports (Module 2.4 and 2.6)
  • Clinical Experts Reports (Module 2.5 and 2.7)

J. V. A. G. has active association with the Best Approved and EU/US agency audited CRO’s for performing the BA/BE Studies. Also collaborates with different Bio analytical Clinical Labs and Clinical Site to acknowledge you with.

  • Clinical site identification and contract negotiation
  • Clinical trials management and monitoring
  • Data management
  • Biosatatistical data of the same
  • Quality assurance auditing
  • Medical writing of Preclinical tests and Clinical Trials (eg. Study Design, Study Protocol, Case                Reports Forms, Study Report  and the Final Report)

Also helps in Phase II, III, IV Clinical trials and toxicity studies

Technical Support

We can help you to increase your professional value in Pharma background in following manner:

In and out licensing of Dossiers and also advise you on strategic, cost effective and innovative product development planning’s system setups for cGMP according to WHO/USFDA/MHRA/MCC/ICH Guidelines as well as GMP compliance, starting from Plant Design to GMP approval by any regulatory Agency Worldwide.

We provide support by giving post submission query response and the expert’s opinion on the same.

The technical advices required for scale up and Tech transfers Projects for Finished Formulations; various dosage forms and to legal services.

J. V. A. G. performs pre-audits and has expertise in COS/CEP preparation, compilation as well as submissions.

Trainings

J. V. A. G. has an organization based Regulatory training programme for the Students and Regulatory Professionals.

 

 

Intellectual Property

  • Comprehensive patent searching, analysis & legal opinion,  Patentability check, Patent landscaping, Freedom to operate / practice (FTO), Invalidation & Litigation support, Technology maps
  • Drafting provisional & complete patent specifications for India and overseas
  • Filing and prosecuting applications at the Indian Patent Office and under the PCT
  • Filing and prosecuting applications internationally in co-operation with our foreign associates