Regulatory Ventures / Affairs

Regulatory affairs professionals are the key associates and the primary communication linkers between the company and the agencies such as FDA, and are responsible for keeping up with the increasing scope and complexity of regulations.

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 regulators to ensure compliance with applicable regulations.

We review regulatory requirements in detail, suggest ideas, and provide support for quicker development at every step. Our regulatory expertise ensures detailed 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 the 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 Equipment
• Export Licenses for Biological Samples and Residual Investigational Product
• Registration of Clinical Trials in National Registries
• Safety Reporting: SAE, Annual Reports, and Safety Reports