A team of regulatory professionals with a wide variety of experience undertake the responsibility from conceptualization of your regulatory needs to planning, execution, and completion.
● Registration of pharmaceutical products – Drugs, Vaccines, Biologicals, Medical Devices, FDC and Cosmetics
● Maintenance of the marketing authorisations and renewals
● Manufacturing site registration
● Control of packaging and promotional material and other marketing related services.
● On-site placement of regulatory staff according to the client’s needs.
● Effective deals with the authorities and intensive follow-up in every submission, in order to ensure timely conclusion of the national phase of the procedures
● Consultancy services concerning the local regulatory provisions and requirements
● Consultancy services for medical devices, cosmetics.
Support for Observational Studies
● Support in overall study plan and process
● Prepare questionnaires for the observational studies
● Conduct observational studies
● Statistical analysis of the data collected
● Preparation of study report
● Writing manuscript as per format of specific journal
The regulatory team provides training program on all aspects of regulatory activities to the various stakeholders in clinical research and drug development. To know more about our training services, please click here.