Advaita Pharmasol Pvt. Ltd.

About Advaita Pharmasol Pvt. Ltd.

Our core activity is preparation of DMF / dossiers / CTD / COS / GMP / eCTD. We provide comprehensive solutions for preparation, filling and registration and updates of drug master files (DMF) for API and registration dossiers for formulations. We are an expert in CTD / ACTD dossiers for formulations. We have expertise and experience in preparation, filling and successful registration of COS or DMF for APIs, excipients and packaging materials. We also undertake bioequivalence/toxicity and Phase II III and IV clinical study projects. We also undertake technology transfer projects for finished formulations and APIs.

  • IN
  • 2015
    On CPhI since
Contact info

Products from Advaita Pharmasol Pvt. Ltd.

  • Dossier services

    Product Dossier services

    J.v.a.g. Pharma consultants provides a highest quality advice and assistance in technical and regulatory aspects of pharmaceuticals which includes dossier services. It involved in preparation and registration of dossiers that forms the integral part of marketing authorization of pharmaceutical products. It includes ctd’s, actd’s, ectd’s etc.for tablets, capsules, injections, metered dose inhalers, dry powder inhalers, nebulisers, gels and ointments and different dosage forms.
  • Dmf's preparation, registration and filing

    Product Dmf's preparation, registration and filing

    J.v.a.g. Pharma consultants provides a highest quality advice and assistance in technical and regulatory aspects of pharmaceuticals which includes dmf’s preparation, registration and filing. It 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.
  • Clinical and nonclinical support

    Product Clinical and nonclinical support

    J.v.a.g. Pharma consultants provides a highest quality advice and assistance in technical and regulatory aspects of pharmaceuticals which includes clinical and nonclinical support. It includes literature research, preclinical experts reports, etc. It provides the best approved and eu/us agency audited cro’s for performing the entire ba/be studies.
  • Technical support

    Product Technical support

    J.v.a.g. Pharma consultants provides a highest quality advice and assistance in technical and regulatory aspects of pharmaceuticals which includes technical support. It includes 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 al by any regulatory agency worldwide. It provides support by giving post submission query response and the expert’s opinion on the same.
  • Trainings

    Product Trainings

    J.v.a.g. Pharma consultants provides a highest quality advice and assistance in technical and regulatory aspects of pharmaceuticals which includes trainings. It has an organization based regulatory training programme for the students and regulatory professionals.