CLINICAL TRIAL MANAGEMENT AND PHARMACOVIGILANCE Preparation of Protocols and CRF design Project Resource Planning , Allocation, Scheduling and Analysis Patient Safety Monitoring and Adverse Event Reporting SAE Management, Collection, Data entry, Event term selection and  Active query process Preparation of Annual Safety Reports(ASRs), Periodic Safety Update Reports (PSURs) read more

INTERNATIONAL REGULATORY DESK STRATEGIC PLANNING Strategic Planning for Product Development. Critical Path Analysis of R&D programs. Regulatory and Technical due-diligence Identification of Global Regulatory requirements Assistance with Regulatory Audits and Inspections read more

DATA MANAGEMENT AND TECHNICAL WRITINGS Preparation of regulatory submissions for FDA, EMEA, TGA, AFSAAPS, MHRA, DCGI, MHLW Assessment of data suitability for registrations Liaison with local Regulatory Bodies Training / Counseling of the Regulatory affairs staff Customized in-house Seminars on Regulatory topics read more