Raju Tippimath Email & Phone Number

Post graduate in Pharmacy with 20 years’ experience in Oral, Parenteral, Ophthalmic, and Topical dosage forms. Expertise in Formulation Development, Project Management, External Partner Management, Tech transfer and Deficiency response management. Projects of US ANDA, 505(b)(2), European CTD, Canadian-ANDS and Proof-of- concepts projects- for Europe/Turkey Market. Product Life cycle management activities. Setting up Greenfield FRD Lab and Pilot GMP lab for Oral solids/liquids, Parenteral and Topical formulations. Execution of contract research development programs with international customers - US and EU customers. Travelled to US, UK, Turkey and Greece for tech transfers. Co-ordination with External Development Partner Centers/CRO/CMO sites for Product development, Tech transfers and commercial launch activitiesProject charter preparation, Review of agreements, Budget preparation, Project management plan, Resource management, Stakeholder management, Monitoring and control of projects. Risk management, Conflict managementCo-ordination with In-house Advanced characterizations teams and external and offshore analytical CRO centers for Extractable and Leachable study and Nitrosamine evaluation study. Elemental risk assessment and evaluation. Documentation support of “Design Control” for Drug Device Combination Projects. Expertise in setting up the Formulation Development Lab and Contract Research Projects.

Listed skills include Regulatory Affairs, Fda, R&D, Formulation, and 25 others.