Regulatory Intelligence And Strategy

With our years of expertise, collaborations and strong network of industry contacts, we provide insightful analysis of Indian regulatory scenario for Pharmaceutical, Food, Nutraceutical, Cosmetic, Medical Device, Diagnostic Kits, Biologicals and Vaccine industry.

Product analysis and feasibility

We do a thorough product analysis and analyze the category for filing the product as per the regulatory framework.

The regulatory scenario of the country have influence on the approval of the product. It is therefore necessary to be aware of the new regulations or updates. Our strong roots in the industry and professional guidance provides you with the know-how of the updated guidelines and regulations facilitating the filing of appropriate documents for hassle free approvals.

We can act as authorized agent/registration holder on your behalf for speedy import and market entry of your products.

The application checklist for different product as per the guidelines are mandatory to be followed for successful submissions. We provide assistance in compiling the documents and its validation as per guidelines.

With our team of experts the slightest details and updates as per the regulations are monitored and communicated to the client for labelling compliance minimizing the chances of queries.

We help our clients throughout the process of regulatory procedures providing step by step hand holding support for successful submission.

The timelines for submission of the application are well communicated to our clients. We also assist in timely query responses to our clients filing the appropriate quality documents reducing the chances of rejection.

Distribution Pathway is a combination of right Distributor Identification and Distribution Point. We provide assistance to the importers for identification of distributors with strong networks enabling right distribution and sales of their products.

Any post marketing changes on the product are notified to the regulatory authorities as per the formats applicable on behalf of our clients. We are in collaboration with Pharmacovigilance companies and can help the clients to monitor the effects of medical drugs in post approval marketing. We also write and review the Periodic Safety Update Report (PSUR) and Adverse Drug Reaction (ADR) reports for our clients enabling them to submit the data to regulatory authorities in India.

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