Our Regulatory Affairs department has competency in handling multiple regulatory activities from clinical trial applications to marketing authorization. Our team has worked on clinical trial permission and marketing authorization of Drugs, Biologics and Medical Devices. Our team with their expertise in regulatory consulting and help to address the requirement of sponsors, investigators and also to the regulators 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 and this helps in improve efficiency, accelerating timelines and reduce delays.
We offer a full range of regulatory services from designing of overall regulatory strategy to marketing authorization and post approval life cycle management. We also have regulatory liaising 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