Regulatory approvals, planned from the first dossier page.
Stenova Medex is a regulatory affairs consultancy in Ahmedabad. We prepare, file and maintain registrations for pharmaceuticals, medical devices and nutraceuticals in India and international markets.
COMPLEX REGULATIONS? WE SEE SOLUTIONS.
Every regulatory challenge has a solution. From complex dossier requirements to global market registrations, Stenova Medex helps you navigate regulatory challenges with clarity, precision and confidence.
Select a challenge to discover how we can help.
LEARN. APPLY. ADVANCE.
Build practical regulatory expertise with industry-focused learning designed to help pharmaceutical professionals understand global submissions, compliance and market access.
EXPLORE COURSES →Regulatory Affairs Career Accelerator
Become a Job-Ready Pharma Regulatory Affairs Professional.
Learn CTD, ACTD, DMF & Global Regulatory Submissions with Real Industry Dossiers.
- Global regulatory pathways
- CTD requirements
- Dossier preparation
- International submissions
Regulatory pathway finder
Pick a product and market to see the usual route to approval.
Indicative overview only. Exact requirements depend on product, class and current rules.
Confirm with an expertMarkets we register in
Each authority has its own format and timelines. We map the route before work starts.
How an engagement works
Fixed scope, clear milestones and one point of contact from scoping to approval.
Start with a scoping callAbout Stenova Medex
Stenova Medex Pvt. Ltd. supports manufacturers, exporters and start-ups that need dependable regulatory work. Our team combines scientific understanding of the product with current knowledge of each authority's expectations. Based in Ahmedabad, a major pharmaceutical hub, we work with formulation, API, nutraceutical and device companies.
Leadership and team
The people who prepare, review and file your submissions.
What we need to begin
Having these ready shortens the scoping stage. Gaps are fine; we flag them in the gap analysis.
Common questions
Do not see your question? Write to us and we will answer within one working day.
Ready to plan your next registration?
Request a consultationContact us
Share your product and target markets. We reply with a scoping plan and timeline estimate.
OfficeAhmedabad, Gujarat, India
Phone+91 73773 83583
ConfidentialityWe sign an NDA before receiving any documents.