Chitra Trimukhe Email & Phone Number

Navi Mumbai, Maharashtra

Development of Generic Products for regulated market. ▪ Literature Search related to Product patents, Patent claims and their interpretation, Patent Non-infringement strategies, Para III and Para IV development. ▪ Preparation of Product Development Plan, Technology Transfer Document. ▪ Pre-formulation studies related to API, selection of excipients and polymer grades for development. 2 ▪ To carry out Product Development trials, Optimization trials, Scale- up trials. ▪ Co-ordination with Regulatory, Analytical, IPM, Purchase department for successful development and filing of generic product. ▪ Development of Quality by Design (QbD) plan for product, its execution and interpretation of outputs. To find out the Critical Material Attributes and Critical Process Parameters. ▪ Address queries of client related to product during development. ▪ Justification to regulatory authorities on queries of filed products. Worked on: Sterile Liquid Dosage form ▪ Anti-emetic -Motion Sickness. Prototype Identified (Market – Europe) ▪ Development of an antiprotozoal Oral Suspension (Market – US) ▪ Development of Injectable dosage form for regulated marke Developed an Anti-Glaucoma ophthalmic dosage form having two strengths and series (Market – US) ▪ Development of Container Closure system for Injectable dosage form. ▪ Execution of filter, material contact, tubing study, filter validation study to identification of compatibility with finished product. Sterile liquid dosage form, Sterile semi solid dosage form, Semisolid Dosage form ▪ Ophthalmic solution/Eye Drops of anti-glaucoma drug (US, AUS, EU market) ▪ Ophthalmic Solution of Antimicrobial drugs (US market EU market). ▪ Ophthalmic suspension of Antimicrobial drugs (US market EU market). ▪ Topical Cream of Anti-inflammatory drug (ROW market) ▪ Preparation of MFC,SOPs ▪ Preparation of Product Development report as per US and Europe marker as per ICH guideline ▪ CRL query response preparation and justifications

Mumbai Area, India

Formulation and development of sterile formulations such as Ophthalmic solutions, emulsions ,ointments Inhalation solution, suspension Nasal suspensions, solutions. Performing pre-formulation studies Preparation of development plan Conducting trail designing ,planning and execution Trial documentation Preparation of Technical information sheets throughsoftware Preparation of stability protocols and follow up for thesame Preparation of study protocols of compatibility studiesand reports of the same Preparation of Assessment batch reports Compilation of analytical data

Master’S Degree, Pharmaceutics

Activities and Societies: Studies on Transdermal Drug Delivery System under guidance of Dr(Mrs.) Namita D.Desai. Project includes.

Bachelor’S Degree, Pharmaceutical Sciences

Activities and Societies: Secured regular student award.  Secured consolidation prize in poster competition held at two day seminar.