Sandeep Sukumar Email & Phone Number

Bengaluru Area, India

# Responsible for the development and evaluation of ophthalmic formulations.# Design of Pre-clinical studies and end point determination for the new developed formulation by working along with pre-clinical team.# Involved in conduction of Pre-clinical studies and interpretation of the data for betterment of the formulation.# Preparing product presentations with new ideas for formulation of a particular drug.# Check the feasibility of development of the new idea.# Work out budget calculation for the assigned projects.# Conduct product discussions with superiors on new strategies of development like 505(b)(2).# URS & SOP preparation

Bengaluru Area, India

# Product development for regulated markets (US & Europe)# Development of Parenteral dosage forms - Liquid injection, lyophilized products.# Literature survey, pre-formulation studies and formulation trials leading to identifying a suitable composition for the product (Q1 & Q2 parameters).# Preparation of documents like, Product Development Plan (PDP) with QBD approach, development study protocol, compatibility study protocol.# Initiation of development trials, optimization of trial, record experimental data, analyze results and maintain accurate and up-to-date product book, documentation details as per Good Documentation Practices.# Providing suitable inputs for the Master manufacturing documents like MFR, Product specifications based on the developmental results.# Execution of Exhibit batches in co-ordination with plant and technology transfer team.# Providing suitable inputs to regulatory team to enable them for filling of product dossier from the developed product.# Handling CMC Queries from the regulatory, taking necessary initiatives and necessary trials for providing the responses.

M. Pharmacy, Pharmaceutics

B. Pharmacy, Pharmacy