Your Trusted Partner for
Regulatory & GMP Services

At RGInsight LLP, we provide integrated support to pharmaceutical and biologics companies seeking to expand into Regulated, Emerging, and Domestic (India) markets. Our approach combines regulatory, technical, and commercial expertise to ensure smooth and compliant market entry.

We assist clients with GMP compliance services, including manufacturing site assessments, gap identification, inspection readiness programs, and coordination with Qualified Persons (QPs) and local regulatory authorities. Whether preparing for EU-GMP, USFDA, or WHO inspections, our team ensures that your facility and documentation are aligned with the latest global standards.

For companies preparing to enter new markets, RGInsight offers complete support for Marketing Authorization Applications (MAA). This includes country-specific regulatory strategy, preparation and submission of dossiers in CTD/eCTD formats, query handling, and lifecycle management services such as variations, renewals, and MA transfers. We work closely with local agents and regulatory consultants in each region to ensure accurate, timely submissions and approvals.

In addition to regulatory support, we help our clients build a strong commercial presence by identifying and connecting them with trusted local distributors and marketing authorization holders (MAHs). Leveraging our well-established global network, we facilitate commercial alliances that are both compliant and strategically aligned, helping clients achieve sustainable growth in new markets.

Whether you are launching your first product internationally or expanding your existing footprint, RGInsight acts as your strategic partner—streamlining regulatory pathways and unlocking market potential across global geographies.

Global Regulatory Experience

Europe

ASEAN

CIS

Africa

MENA

LATAM

GCC

Canada

Comprehensive Regulatory Support

Expert services for regulatory, quality, and export needs in pharmaceuticals and biologics for businesses.

Global Network Access

Connect with trusted distributors and enhance international collaborations for seamless market entry and growth.

End-to-End Services

We provide complete regulatory support, ensuring faster and cost-effective access to global markets.

Our industry experts guide you through every step of the regulatory process for successful market entry.

Expert Guidance

Our Regulatory Service Models

For Specific Projects or one-time requirements

A Smarter Approach to Regulatory Submission Management

Managing regulatory affairs doesn’t have to be complex or costly. With our subscription-based regulatory support model, you gain access to a dedicated team of trained professionals—without the hassle of hiring, training, or managing an in-house department. Whether you're a startup scaling up or an established company aiming to streamline compliance, our fixed-cost model ensures clarity, control, and continuity.

Our Project-Based Regulatory Outsourcing Model is designed to provide end-to-end regulatory support tailored to specific projects or deliverables—offering maximum flexibility, cost-efficiency, and domain expertise. You can get access to a dedicated team of experts in CMC, clinical/non-clinical, eCTD publishing, regulatory strategy, and region-specific requirements for your small no. of projects.

Subscription Based

• Fixed Monthly Cost. Predictable Budget.

• Annual Product Registration Included.

• Operational Savings Without Compromise.

• Expert Regulatory Support—Always On.

• No Hassle of Training—Skilled Professionals at Your Service.

• No Recruitment Headaches—We’ve Got You Covered.

Project Based

• Defined Scope, Timelines & Deliverables

• No Long-Term Commitment

• Access to Multi-Disciplinary Expertise

• End-to-End Regulatory Execution

• Scalable & Agile

Ideal For

• SMEs with no or small in-house regulatory team

• Companies entering new markets,

• Clients requiring quick turnaround for urgent submissions

• Partnering for dossier readiness pre-out-licensing

Get in Touch

Contact us for regulatory and export service inquiries today.