Our Regulatory Affairs department has competency in handling multiple regulatory activities from clinical trial applications to marketing authorisation. Our team has worked on clinical trial permission and marketing authorization of Drugs, Biologics and Medical Devices. Our team of regulatory expertise support sponsors and investigators to ensure compliance with applicable regulations.
We review regulatory requirement in detail, suggest ideas and provide support for quicker development at every step. Our regulatory expertise ensures detail project planning and strategies to meet legislative requirements.
We offer a full range of regulatory services from designing of overall regulatory strategy to marketing authorisation and post approval life cycle management. We also have regulatory liasoning expertise with deep knowledge of legislation and regulatory environment.
We are specialized in managing the following regulatory activities:
Review of Technical Dossiers
Preparation and Submission of Regulatory Dossiers for Clinical Trial Approvals and Marketing Authorizations
Liaisoning with Regulators for Submission and Approvals
Presentation of Protocols to Regulatory Expert Committees (NDAC, SEC and MDAC in Case of DCGI Submission)
Import Licenses for Investigational Products, Ancillary Supplies and Equipments
Export Licenses for Biological Samples and Residual Investigational Product
Registration of Clinical Trials in National Registries
Safety Reporting: SAE, Annual Reports and Safety Reports