Regulatory & Compliance Services

1. Regulatory Compliance Advisory

Expert guidance to ensure compliance with national and international regulations.
Assistance in navigating complex regulatory frameworks and building strategies accordingly.
Regulatory services for pharmaceuticals, biologicals, medical devices, nutraceuticals, herbal, homeopathic, diagnostic kits and cosmeceuticals.

2. Licensing and Registration Support

Assistance in obtaining required licenses and permits.
Facilitation of business registration with regulatory authorities.

3. MAH / LR for International Clients

Act as Authorized Representative / Marketing Authorization Holder / Registration Holder.

4. Regulatory Filing and Documentation

Preparation and submission of regulatory filings and documentation.
Maintaining up-to-date regulatory records.

5. Regulatory Audits and Inspections

Facilitation of audits and inspections.
Support during inspections with accurate reporting.

6. Customs and Import/Export Compliance

Support with customs regulations for import/export.
Advice on tariff classifications and trade laws.

7. Regulatory Advocacy and Representation

Representation before regulatory bodies and government agencies.
Advocacy aligned with regulatory frameworks.

8. Risk Management and Mitigation

Identify compliance-related risks and develop mitigation strategies.
Proactive solutions to prevent regulatory penalties and ensure continuity.