Regulatory and Safety Services

Indegene’s Extended Enterprise Models help organizations achieve their Regulatory and Safety goals


Indegene supports the Regulatory and Safety divisions of several leading life sciences companies, with a proven track record of successful partnerships and development of a number of high-quality regulatory and safety documents across pre- and post-marketing stages. The Regulatory Writing and Safety Services are cost effective, flexible, and have seamlessly been integrated with the needs of various regulators and clients (sponsors) across the world.

The medical writers come from science and medical streams, with ample experience in clinical practice, scientific research, academia, and industrial services. These writers are trained on the basics of drug development, ICH-GCP guidelines, regulatory requirements as well as documents and safety reports for regulatory submission, with expertise and experience in authoring, editing, and providing best quality.

The Extended Enterprises Models provide a unique blend of both onsite and offshore presence and capabilities.
 

Client Benefits

 

  • Dedicated scientific partner to life science companies with an extensive expertise in regulatory and safety services, offering a large pool of trained, efficient, and quality-driven medical resources

  • Established credibility in executing Center of Excellence models with multi-year engagements in the areas of safety documents, aggregate reporting, clinical/non-clinical regulatory documents, and labeling and artwork

  • Highly flexible and scalable customer-centric approach offering a unique Hybrid Global Delivery Model to deliver cost, time, and local expertise

  • Deeply invested in technology—10 patented IPs and highly innovative technology platforms as well as tools to drive efficiency and standardization across service lanes

SOLUTIONS
Pharmacovigilance and Safety Services

Indegene recognizes pharmacovigilance and safety as key areas of strategic partnership as we create dedicated CoE programs that mirror the sponsor organization. LEARN MORE.

Clinical Regulatory Writing

Indegene has an extensive track record of providing quality and efficient regulatory services for its clients. These include customizing protocols to meet regulatory approvals, regulatory dossier submissions, marketing approval and authorization, as well as briefing document and label updates, all of which require a thorough understanding of different templates and requirements for local labels to ensure health authority approval on time. LEARN MORE.

Technical and Non-clinical Regulatory Writing

Besides clinical regulatory services, Indegene has an extensive track record of providing quality and efficient technical/non-clinical regulatory writing services to its clients. LEARN MORE.