Customized consulting solutions and delivery based on product, region and regulatory body to help customers take the appropriate regulatory path.
Wipro’s regulatory expertise helps companies with strategic regulatory guidance and operational support for development of drugs as well as early and late phase commercial programs, and adopt seamlessly to the ever changing regulatory landscape.
Defining the Regulatory Strategy at Wipro
Global regulatory strategy is developed by focusing on the ecosystem comprising regulatory bodies, healthcare professionals, and patients. Wipro’s competency includes establishing regulatory strategies that span from the early drug development stage to post authorization requirements with key milestones and business objectives to achieve required regulatory outcomes.
Our services include:
- Regulatory intelligence services for various health authorities on submission, market authorization and post launch compliance requirements
- ·Reviewing regulatory strategies formulated across molecules and identifying opportunities to simplify and streamline submissions for markets and/or regions
- Interpreting and implementing health authority regulations, guidance, regulatory precedence into submission processes and publishing standards, to ensure final document content and structure are compliant with local regulatory requirements
- Consultation and regulatory support of ad-hoc workload during MAH transfer, tech transfer or merger & acquisition (M&A)
Defining the Regulatory Operations at Wipro
The global regulatory operations function provides end-to-end visibility of regulatory compliance required for drug development, market authorization, and post approval requirements. It deals with logistics and expertise required to maintain the regulatory ecosystem, i.e., developing regulatory documents, ensuring timely submissions as per required format, coordinating with internal stakeholders, and interacting with health authorities on documents submitted for approval while ensuring compliance with all regulations in the areas where the product is marketed.
With the health authority being the primary customer, activities performed under regulatory operations include:
- Authoring, preparing and reviewing regulatory documents/dossiers - Investigational New Drug (IND), Clinical Trial Authorization (CTA), Investigational Medical Product Dossier (IMPD), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), 505b(2), Marketing Authorization application (MAA), Biologics License Applications (BLAs), Drug Master File (DMF)
- Authoring documents - Post approval study at the time of approval of premarket approval (PMA) application
- Gap analysis and evaluation of documents required for filing
- Post approval changes and product lifecycle management
- Authoring of annual reports, variations, dossier amendments, and supplements for regulatory bodies
- CMC submission management process - Providing expertise on internal processes, electronic submission regulations and guidance regarding technical content
- Interacting with various health authorities (FDA, EMA, PMDA, TGA, HC, etc.) and addressing their queries, negotiations, responses
- Literature review and surveillance
- Communicating on regulatory issues with all stakeholders
Regulatory operations are critical for any organization and oversight on the regulatory requirements of regulatory bodies is not an option. Proper coordination with external and internal stakeholders can help to get drug products available in market(s) on time.