Profile Summary

Lead Formulation Development and Process development for solid oral and Liquid oral dosage forms to facilitate First-to-File and Para IV for Regulated Market goals.

Preparation and evaluation of FDA query responses Related to Technology Transfers and Formulation.

Planning and execution of PV batches as per ICH guidelines for various processing technologies to develop robust oral dosage forms Commercialization.

Interpret in-vitro, in-vivo, XRD, PSD etc. data to derive clear conclusions and provide direction for development work.

ANDA and NDA development of robust formulations for solid oral dosage forms for US, EU, Japan, Canada and Australia market.

Review of documents PDR, CDP, BMR, BPR, HTSR, PV Protocols and Reports and Documents for license to Local FDA.

Planning of Pilot, Clinical, Stability and Exhibit batches, Batch Size and Equipment selection and executions with the project scientists to support ANDA filings.

Co-ordinate and interactions with other functional units (ADD, RA, IPR, Quality, etc...) to ensure support for regulatory filings is provided in a timely fashion.

Process-engineering expertise to technology transfer of projects to internal and external manufacturing locations. Provide technical expertise to the project execution team. Perform process engineering analysis to determine cycle time, equipment fit, technologies required, scale up risk etc.

Material knowledge - data-driven procedure to facilitate materials selection and help accelerate pharmaceutical development studies. Good understanding of Physical, chemical and surface morphology of the material in depth, Facilitates the risk assessment of any material in such a way that the drug product development and secondary process selection can be accelerated.

CORE COMPETENCIES (Overall experience includes following specialty dosage forms)

Extended-Release Tablets Capsule Liquid Formulations Suspensions and Solutions

Oral Osmotic release tablets Delayed release capsule with mini tablets and pellets

Drug loading, Divi dose, Till Tablets

NDDS Formulations (Abuse deterrents and Overdose tech)

Bilayer tablets with Immediate and Extended-Release combinations

FDA query responses

API Evaluation and Source Finalization for outsource API

Previous Experience

Morison Pharmaceuticals Ltd Colombo Srilanka

Kunming Jida Pharmaceutical Co., Ltd., China

Medreich (Meiji Seika) Pharma, India

SUN pharmaceutical, India

Lupin Pharma, Aurobimdo India pharma & NATCO Pharma