Bharat Bhat Email & Phone Number

Maharashtra, India

Thrilled to announce my promotion to Associate Director. The journey has been incredible. Over the past year a new responsibilities has been added and no stone remains unturned to accomplish the goal.This promotion means more to me than the word can express. It's the culmination of years of dedication and hardship. I could not have achieved this without a dedicated team and unwavering support from my mentors @Mahendra Barot, @John Derstine and @Janet Vaughn.

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

-Leading development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC requirements, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks for submission.-Responsible to execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support ANDA submissions and… Show more -Leading development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC requirements, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks for submission.-Responsible to execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support ANDA submissions and responses to deficiencies of health authority for Solid Dosage Forms & Non-Solid Dosage forms including Sterile Injectables, Ophthalmic and complex injection.-Experience in submission of complex drug-device combination and peptides products to USFDA and EU market. Show less

Ahmedabad Area, India

-Experience in assembling injectable product dossiers for submission to USFDA.-Plan, coordinate, and write responses to deficiency from USFDA during their review of the submissions.-Responsibilities include Regulatory CMC strategy & risk assessment, preparation/review of high quality submissions, responses etc. for commercial product support (life-cycle management) within matrix environment.

Ahmedabad, Gujarat

ANDA submissions and Life cycle management of injectables,

Vadodara Area, India

ANDA submission for Parenteral's.

Hyderabad Area, India

Responsible for the preparation, maintenance and timely completion of regulatory documents and preparation of eCTD module to support submissions to US FDA & TPD (Steriles).

India

Job Responsibilities:A) Activities related to Tech Transfer products:1. Reviewing the product book, Lab scale batches, analytical results, and discussion with Formulation Development for complete understanding of product and process. 2. Planning and execution of Scale-up batch, which also includes preparation of Manufacturing protocol and its online completion.3. Analysis of Manufacturing process, incorporation of changes with proper justification.4. Approval of… Show more Job Responsibilities:A) Activities related to Tech Transfer products:1. Reviewing the product book, Lab scale batches, analytical results, and discussion with Formulation Development for complete understanding of product and process. 2. Planning and execution of Scale-up batch, which also includes preparation of Manufacturing protocol and its online completion.3. Analysis of Manufacturing process, incorporation of changes with proper justification.4. Approval of Master Formulation Record (Finalized manufacturing procedure on the basis of Scale up batch), conduction of Cross Functional Team (member comprising of Plant –QA, QC, Production, and R&D QA, QC, FD, Packaging, Strategic Sourcing Department and Technology Transfer Department).5. Execution of Exhibit Batches and on approval Execution of Process Validation Batches. B) Activities related to Site Transfer products:1. Preparation of GAP analysis which mainly comprises of comparison between process requirements and available facility. Highlighting new requirements, possibility of media fill, feasibility trials, Raw Material and Primary Packaging material requirements, review of analytical data, lead time required for availability of resources to kick start the project.2. Conducting trials and to get familiar with the manufacturing process.3. Project costing, coordinating with strategic sourcing department for procurement, preparation of tracking sheet of materials (RM, PM, Secondary Packing material, equipments)4. Preparation of MFR, Packing record, specification (In-Process, Finished product) and review of standard test procedure, preparation of stability protocol.5. Conducting hold time study and filter validation study.6. Conducting optimization batches scale up batches as per the time lines framed by the mutual agreement between customer and receiving site.7. Compilation of trial and scale up data, making reports with proper justification for any process related changes. Show less