About Us
RGInsight (RGI) is your trusted partner in navigating the complex pharmaceutical and biologics landscape, specializing in Regulatory Affairs, GMP Compliance, and acting as a strategic sourcing partner for export.
Our team of seasoned industry experts delivers end-to-end regulatory support, enabling companies to achieve faster, more cost-effective market access across global markets. From product development to post-approval lifecycle management, we ensure every stage aligns with the latest international regulatory standards.
Through our strong global network, we connect Indian manufacturers and exporters with trusted international distributors, facilitating seamless collaborations, regulatory success, and long-term business growth.
Our Mission
To assist you in scope identification, strategic planning, and subsequent submissions by providing complete solutions tailored to your organization’s purpose.
Our Vision
To be the preferred global consultancy service provider, supporting client organizations with tailor-made services and fully integrated regulatory support.
Reena Aggarwal
Geeta Verma
Manish K Sharma
She brings approximately 23 years of experience in the top Indian Pharmaceutical and Biopharmaceutical industries in Regulatory Affairs and Quality Control. She brings to the team:
Specialisation in dossier filing strategies for regulatory approvals.
Expertise in marketing authorization across various global markets.
Proficiency in handling deficiency responses and regulatory queries.
Extensive experience in dossier submissions for Europe, Emerging Markets, Rest of the World, and CDSCO.
Expertise in comprehensive life cycle management of pharmaceutical products.
She brings over 20 years of experience as a Regulatory Affairs professional, with in-depth knowledge of regulatory strategies for the USA, Europe, and Emerging Markets. She has successfully managed numerous ANDA submissions and original EU Marketing Authorization Applications across a range of dosage forms, including MDIs, injectables (both lyophilized and liquid), and topicals.
An expert in life cycle management, she has overseen regulatory activities for a significant number of pharmaceutical products for the US and EU markets. With a proven track record in the development and execution of global regulatory strategies, she is adept at navigating complex regulatory frameworks to ensure compliance and secure timely product approvals.
He brings approximately 22 years of experience in the Pharmaceutical and Biopharmaceutical industries, specializing in sterile and non-sterile formulations. As a Certified Quality Auditor, he conducted GMP/GLP audits across multiple sites. He has been instrumental in gap assessments and successfully achieving international regulatory certifications such as USFDA, EU-GMP, MHRA, and TGA for various manufacturing sites in India. He was responsible as the primary auditee for seven USFDA, EUGMP, UKMHRA, and WHO-Geneva inspections, along with audits from regulatory bodies like ANVISA, COFEPRIS, MFDS (Korea), TFDA, MOH-Gulf, and WHO-GMP, among others.
Our Team
