Healthcare Regulatory Affairs & Market Access Consulting in India
Expert regulatory strategy and compliance support for medical devices, pharmaceuticals, IVDs, biologics, and cosmetics across Indian and global markets.
Our Regulatory Expertise
Comprehensive regulatory affairs support across all major healthcare product categories in India and global markets.
Medical Devices
End-to-end regulatory support for medical device registration, licensing, and compliance under CDSCO and MDR 2017.
- CDSCO registration
- MDR 2017 compliance
- Import licensing
- Post-market surveillance
In Vitro Diagnostics
Regulatory strategy and submissions for IVD products including test kits, reagents, and diagnostic instruments.
- IVD classification
- Performance evaluation
- CDSCO submissions
- CE marking support
Pharmaceuticals
Dossier preparation, new drug applications, and lifecycle management for pharmaceutical products.
- New drug applications
- Dossier preparation
- CTD/eCTD formatting
- Regulatory strategy
Clinical Research
Protocol development, ethics committee submissions, and regulatory oversight for clinical trials in India.
- Protocol development
- Ethics submissions
- CDSCO trial approvals
- GCP compliance
Biologics & Biotechnology
Regulatory pathways for biosimilars, vaccines, blood products, and advanced therapy medicinal products.
- Biosimilar dossiers
- Vaccine submissions
- ATMP guidance
- Comparability studies
Cosmetics
Compliance and registration support for cosmetic products under the Drugs and Cosmetics Act and BIS standards.
- Product registration
- Labelling compliance
- Safety assessments
- BIS standards
A Trusted Regulatory Partner
ARV Reguplex brings deep expertise in Indian and international regulatory frameworks, helping healthcare companies navigate complex approval processes with confidence and efficiency.
About UsDeep Expertise
Years of hands-on experience across all major healthcare product categories.
Client-Centric
Tailored strategies aligned to your product, timeline, and business goals.
End-to-End Support
From pre-submission planning through post-approval compliance.
Transparent Process
Clear communication and regular updates at every stage of the regulatory journey.
Ready to Navigate Your Regulatory Journey?
Let's discuss your product's regulatory pathway and how ARV Reguplex can help you reach market faster.