Nirav Sheth Email & Phone Number

Gurugram, Haryana, India

• Responsible for review and release of specifications, ATP and related documents including API for US and Emerging Market
• Responsible for query related activities related to analytical development and its implementation of learning in ongoing similar development / filing projects.
• Responsible for conducting specification meeting for Oral project for all advanced and EM market.
• Responsible for review / evaluation of analytical documents, Validation reports, Verification reports, justification reports, which are submitted to various agencies.
• Support to resolve Technical issues related to Documentation, Specifications, Analytical Method Validation / Verification.
• Responsible for outsourced DMF /CEP review for ongoing development projects for various markets.

Vadodara, Gujarat, India

Analytical Compliance Cell: Literature review and evaluation of polymorphic form of various API. To prepare the Method development Report / Polymorphic Report of Drug substance. To ensure the development and validation activity of XRD, for drug substance and drug product both, on the basis of literature review. To prepare protocol and report for the.

Vadodara

 Successfully lead a team for NDDS, ANDA and Domestic product. Method development of ANDA, NDDS and Domestic product. Validation of ANDA, NDDS and domestic product on the basis of ICH guidelines. Monitored and reviewed method transfer protocols and reports for raw materials and finished products. Review of stability data for R&D and scale up data as.

Plan and conduct analytical activities associated with the development and testing of both generic and innovative drugs.Method transfer for raw materials and finished products.Validation of newly developed method of ANDA product including cleaning validation for the US market.Regularly reviews of projects/assignment of validation before submissionRespond.

JOB PROFILE- Develops and manages the operating and capital budgets for the division.- Preparation and reviewing the protocols and documents of validation. - Managing the method development for pharmaceuticals preparations. - Preparation, maintaining and characterization of Reference and Working Standards.- Conduct physical characterization of drugs..

Overall in charge of shift.Performed in-process and finished product testing as per the compendial and in-house methods.Performed raw material testing of products as per the specified method.

Master Of Science, Analytical Chemistry

Bachelor Of Science, Chemistry

Diploma In Marketing Management