Pharmaceutical Dossier is an Important & Critical part of Product Registration process, which is need to submit in Food & Drug Administration of the concerned Ministry of Health, of Regulatory Authority.
Different Regulatory Authority published their Standard format according to country Guidelines
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. collaborates with different renowned laboratories to provide with Analytical Studies, Validation, Elemental Analysis, Stability etc. for the active ingredients as well as pharmaceutical products.
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.