Regulatory Affairs
Drug development to commercialization is governed and regulated by global Health Authorities in ensuring compliance throughout the process across the product life cycle, organizations deploy proven experts for Regulatory Affairs. The expert team track regulations related to the product and per-requisites for its launch, in fact a crucial role between organization and global Health Authorities. In the current situation, not many organizations have the privilege to have these teams in-house given their dedicated focus and approach towards innovation and drug safety.
Revive, a specialized global Regulatory Affairs partner acts as a bridge between organizations and key regulators like, the US FDA, Health Canada, and the European Health Authorities. Revive provides strategic multidisciplinary comprehensive Regulatory affairs services across the spectrum of product development, registration and commercialization.
Revive’s global Regulatory affairs services enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize their market value.
Our integrated cross-functional expertise and flexible sourcing for regulatory services helps you navigate complex regulatory requirements throughout your product’s development lifecycle enabling the probability of successfully registering the products with Drugs Controller General India and Directorate General of Foreign Trade. The in-depth knowledge of local regulatory procedures and dedicated and effective liaisoning with various regulatory agencies that ensures high efficiency in the Clinical Trial approval process.
Services offered include but not limited to
- Compiling dossiers
- Executing regulatory submissions
- Preparation & submission of complete range of regulatory documents for obtaining:
- Approval to conduct clinical trial in India
- Approval to import Test Drug
- Approval to export Biological Samples
- Liaisoning and Obtaining registration documents in the interest of clients
- Continuous follow-up post submission with regulatory authorities
- Renewal of Import license
- Safety reporting
Regulatory offerings will be successfully in completing the audits from Indian & International regulatory agencies, sponsor audits from Indian and International clients and study submissions will also be made to other countries.
Revive Motto
- Submission Forecast and Planning
- Submission Document Management and Tracking
- Regulatory Content Management
- Change Control Management
- Label Change Tracking
- Integrated Regulatory Information & Intelligence
- Reporting and Analytics