Comprehensive Regulatory Support for Pharmaceuticals and Biologics Across Global Markets
At RGINSIGHT (RGI), we are dedicated to empowering pharmaceutical and biologics companies with seamless, end-to-end solutions that drive success in Regulated, Emerging, and Domestic (India) markets. Our expertise spans the entire product lifecycle—from ensuring GMP compliance to securing marketing authorizations and establishing robust distribution networks.
Marketing Authorization Applications and Approvals
Navigating the complexities of marketing authorization is our specialty. RGI manages the entire application process, from dossier preparation and submission to responding to regulatory queries and securing timely approvals.
We have a proven track record of success with regulatory authorities in highly regulated regions (such as the US, EU, and Japan), as well as in fast-growing emerging markets and India.
Our regulatory experts tailor strategies to each jurisdiction, ensuring your products achieve swift and compliant market access.
Local Distributor Identification and Partnership
Entering new markets requires trusted local partners. RGI leverages its extensive industry network to identify, evaluate, and connect you with reliable distributors who align with your business goals and product profile.
We facilitate negotiations and partnership agreements, ensuring your products reach healthcare professionals and patients efficiently and compliantly.
GMP Compliance Services
RGI provides expert guidance and hands-on support to help clients achieve and maintain Good Manufacturing Practice (GMP) compliance, a critical requirement for market entry and sustained success in the pharmaceutical and biologics sectors.
Our team conducts in-depth GMP audits, gap assessments, and training sessions, ensuring your manufacturing processes meet the highest international standards and withstand rigorous regulatory scrutiny.
Why Choose RGI?
Global Reach, Local Expertise: Our team combines deep knowledge of international regulatory frameworks with on-the-ground insights in emerging and domestic markets.
End-to-End Project Management: From GMP audits to post-approval support, we manage every step, allowing you to focus on innovation and growth.
Client-Centric Approach: We tailor our solutions to your unique needs, ensuring maximum value and regulatory success.
Partner with RGINSIGHT to accelerate your pharmaceutical and biologics journey—achieve compliance, secure approvals, and build strong market presence across the globe.
Dossier Preparation and Submission
We offer end-to-end support for electronic Common Technical Document (eCTD) submissions, including:
eCTD Compilation, QC Review, Technical Validation, and Submission Hosting. This minimizes manual errors, improves consistency, and accelerates the review process.
eCTD Lifecycle Management
Baseline eCTD Preparation – Converting dossiers from Paper, CTD, or NeeS formats to eCTD
Importing and Cloning of Existing eCTD Applications
RGINSIGHT’s capability to handle simultaneous multi-agency submissions and adhere to evolving guidelines (such as those for data transparency) further reduces waiting times and administrative bottlenecks
eCTD Services
