Regulatory Consulting Across the Healthcare Spectrum
ARV Reguplex provides end-to-end regulatory consulting for pharmaceuticals, medical devices, IVDs, biologics, clinical research, and cosmetics. We help clients identify the right regulatory pathway, prepare compliant documentation, and navigate submissions from first filing through post-approval lifecycle.
Regulatory Areas
We work across six primary regulatory domains, each with its own applicable frameworks, regulatory bodies, and submission requirements under Indian law.
Medical Devices
Regulatory strategy and submission support for medical devices under the Medical Devices Rules, 2017. We assist with device classification, import and manufacturing licences, technical documentation, and CDSCO submissions for Class A through Class D devices.
- Device classification & risk assessment
- Import & manufacturing licence applications
- Technical documentation & labelling review
- CDSCO submission & query response
In Vitro Diagnostics (IVD)
Dedicated regulatory support for IVD products including diagnostic kits, reagents, and instruments. We cover classification, performance evaluation documentation, and regulatory submissions under the applicable IVD framework.
- IVD classification & applicable rules
- Performance evaluation & technical file
- Import & manufacturing licence support
- Labelling and instructions for use review
Pharmaceuticals
Comprehensive regulatory support for new drug applications, generic drug filings, and import licences under the Drugs and Cosmetics Act. We assist with dossier preparation, Schedule Y compliance, and CDSCO interactions.
- New drug & generic drug applications
- Import licence & manufacturing approval
- Schedule Y dossier preparation
- Regulatory query response & liaison
Clinical Research
Regulatory support for clinical trials and bioavailability/bioequivalence studies conducted in India. We assist sponsors and CROs with protocol review, ethics committee submissions, CDSCO applications, and compliance with the New Drugs and Clinical Trials Rules, 2019.
- CDSCO clinical trial applications
- Ethics committee submission support
- BA/BE study regulatory requirements
- NDCT Rules 2019 compliance review
Biologics & Biotechnology
Regulatory pathway guidance for biologics, biosimilars, vaccines, and biotechnology-derived products. We support clients through the complex approval requirements applicable to these product categories under Indian regulations.
- Biologics & biosimilar regulatory pathway
- Comparability and characterisation guidance
- CDSCO & DBT regulatory submissions
- Post-approval change management
Cosmetics
Regulatory support for cosmetics and personal care products under the Cosmetics Rules, 2020. We assist with product registration, import permissions, labelling compliance, and prohibited/restricted substance reviews.
- Cosmetics registration & import permissions
- Labelling and claims compliance review
- Prohibited & restricted substance assessment
- Market entry strategy for cosmetics
Cross-Cutting Service Lines
Across all regulatory areas, we offer a consistent set of service capabilities that clients can draw on at any stage of their regulatory journey.
Regulatory Strategy
Defining the optimal regulatory pathway based on product type, intended use, and applicable requirements.
Product Classification
Determining the correct classification of a product and the regulatory framework that applies.
Regulatory Submissions
Preparation and filing of applications, dossiers, and supporting documentation with regulatory authorities.
Licensing Support
Assistance with import licences, manufacturing approvals, and other regulatory authorisations.
Technical Documentation
Review and preparation of technical files, dossiers, and product documentation to meet regulatory standards.
Compliance Assessment
Evaluation of products, processes, and documentation against applicable regulatory requirements.
Gap Assessment
Identifying gaps between current documentation or processes and regulatory requirements.
Query Response
Drafting and managing responses to regulatory authority queries and deficiency letters.
Post-Approval Support
Managing post-approval changes, renewals, and ongoing compliance obligations.
Market Entry Strategy
Regulatory planning for companies entering the Indian market for the first time.
Regulatory Intelligence
Monitoring and interpreting regulatory developments, guidance updates, and policy changes.
Discuss Your Regulatory Requirements
Every product and regulatory situation is different. We would be glad to understand your specific requirements and outline how we can help.