Make A Call
Loading
Loading
Expert regulatory consulting services for pharmaceutical and life science companies navigating complex global compliance requirements.
Navigate complex global compliance landscapes with confidence. We ensure your products meet legal, scientific, and quality standards enforced by FDA, EMA, and other global agencies.
Contact us for regulatory affairs consulting services
Clear and accurate regulatory strategy not only demonstrates compliance expertise but also instills trust in partners and stakeholders.
Customized regulatory strategies aligning with your specific business and product needs for optimal outcomes.
Comprehensive support for regulatory compliance across EU, UK, Australia, US, Canadian, and other international markets worldwide.
Comprehensive risk assessment and mitigation strategies to minimize compliance risks and eliminate market entry barriers.
LeadershipRegsetu was founded by a team of seasoned regulatory affairs professionals with 18+ years of proven expertise in pharmaceutical compliance and quality assurance. Their leadership drives our commitment to delivering exceptional regulatory solutions globally.
Our Regulatory ServicesFrom early-stage development to market approval and post-market compliance
Strategic planning and implementation for successful regulatory submissions
Preparation, review, and submission of comprehensive regulatory dossiers
Electronic Common Technical Document publishing services
Preparation and representation for health authority interactions
Labelling services for Europe and USA markets
Design dossiers and declarations of experts
Support through regulatory changes and ongoing compliance
Pharmacovigilance, product variations, and renewals
Our ApproachAll of our regulatory documents and guidance are developed by compliance specialists with deep expertise in both local and global requirements. This ensures every document is accurate, technically robust, and audit-ready.
Our clients include start-ups seeking regulatory roadmaps and established
pharmaceutical companies needing assistance with specialized markets.
We provide tailored solutions that adapt to your specific needs and growth stage.
Our Regulatory Affairs TeamOur regulatory affairs team is comprised of experienced professionals with deep expertise in global pharmaceutical, biotechnology, and medical device regulations. The group includes specialists in clinical/non-clinical writing, chemistry manufacturing and control (CMC), risk management, and product labelling.
Regulatory submissions, dossier authoring, and agency communications
In-depth expertise of FDA, EMA, Health Canada, and regional authorities
Comprehensive guidance and publishing support for regulatory excellence
Collaboration, transparency, and reliability for your success
Champions internal team success and robust compliance at every step
Latest regulatory intelligence and global best practices for excellence
Our team culture blends technical excellence with a commitment to mentorship and innovation, employing the latest regulatory intelligence to anticipate market demands and prepare clients for future success.
Product Designer
IT Consultant
Senior Manager
Web Designer
CEO & Founder
Get In TouchContact us today to discuss how we can support your pharmaceutical compliance needs
contact@regsetu.com
+91 94276 77270