Responsible for planning, execution and management of clinical trials, bio-availability (BA) and bio equivalence (BE) studies undertaken by Clinical Research and Development department for international and domestic markets. • To review and discuss in-vitro data and other relevant formulation attributes in order to evaluate the suitability of test products for BE studies.•To perform thorough literature search and assessment/Interpretation of available in-vitro and in-vivo data so as to recommend suitable study design and approach for the planned biostudies i.e. finalization of biostrategy.• To investigate the plausible causes of bio-equivalence failure in order to understand the reason of failure and to provide an opinion on formulation attributes /dissolution behavior/study design that could help us to achieve the success in upcoming bioequivalence study.

Responsible for planning, execution and overall management of bio-availability (BA) and bioequivalence (BE) studies undertaken by clinical research and development department for international and domestic markets and to ensure that studies are conducted and data generated, recorded and reported is in compliance with the protocol, GCP and applicable regulatory requirements. Also to ensure the timely completion of bioequivalence studies required for product registration in respective country.-Successfully defended Investigational New Drug (IND) proposal before AND committee.

Responsible for handling Bio-equivalence and patient PK studies of complex generic products (Liposomes, Microspheres, Long acting depot suspension, Injectable emulsion etc) for regulated markets

Responsible for planning, designing and execution of bioavailability and bioequivalence studies undertaken for international and domestic markets.Successfully handled more than 100 pivotal BE studies for regulated markets. Bioequivalence studies conducted were a part of 29 ANDAs, 28 DCP applications to EMA, 23 product approvals from TGA & 7 product approval from Health CanadaExperienced in planning and execution of BE studies in Mexico.• CRO identification, selection and budget negotiation.• To undertake audit of identified CROs along with CQA team for evaluating their services, procedures, quality assurance and quality control systems along with infrastructure and personnel to conduct our BE studies. Till date, more than 12 Bioequivalence CROs in India and 8 CROs in Mexico have been audited.• To review BE study protocols and study reports to ensure its completeness with respect to scientific and relevant regulatory agency requirements.• To provide timely response to the queries raised by regulatory authorities after submission of registration dossier and pre-submission queries raised by customer (Till date successfully resolved more than 70 queries from different agencies)• To review and discuss in vitro dissolution data received from formulation department in order to check the suitability of test products for BE studies.• Interpretation of available data to recommend suitable study design and approach for the biostudies. To perform thorough literature search in order to finalize the biostrategy.• To investigate the plausible causes of bio-equivalence failure in order to understand the reason of failure and to provide the opinion on dissolution behavior/study design that could help us to achieve the success in upcoming bioequivalence study.• Closely worked with formulation development, regulatory affairs and international marketing team.

Successfully handled 900 patients Phase III clinical trial of medicinal product involving 21 sites across India.•Developing and drafting study protocol, CRF, IB, PIS, ICF and patient diary and other CT documents.•Identification and selection of investigators for the assigned studies.•Finalizing budget of the selected site for the assigned projects•Doing ethics committee submissions at study sites to seek EC approval•Coordinate with translation beauros, diagnostic kit suppliers, central pathology laboratory etc.•Ensuring that adequate quantities of all the CT supplies are maintained at all the sites till completion of assigned studies.•Administer protocol and related study training to assigned sites.To conduct site initiation, monitoring and close-out visit