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Regulatory & Quality

Compliant by Design, Trusted by Practice

At Aries Drugs Pvt. Ltd., we consider regulatory compliance as the backbone of pharmaceutical manufacturing. Our Regulatory Affairs Policy is rooted in our commitment to patient safety, ethical marketing, and 100% compliance with national standards set by the DCGI (Drugs Controller General of India), CDSCO, and State FDA Authorities.

From product registration to post-marketing surveillance, our regulatory team ensures that every formulation meets the legal, clinical, and operational requirements demanded by India’s regulatory framework.

Core Regulatory Commitments

We are committed to:

  • Adhering to all regulatory requirements under the Drugs and Cosmetics Act, 1940 & Rules, 1945
  • Ensuring all product formulations are approved by DCGI or State FDA prior to commercialization
  • Maintaining up-to-date drug licenses, product permissions, and labeling compliance
  • Regularly reviewing regulatory updates and gazette notifications issued by CDSCO
  • Supporting pharma marketing partners in obtaining and maintaining product documentation

Scope of Our Regulatory Operations

Our Regulatory Affairs Division oversees:

  • New Product Registration & License Applications
  • Formulation File Creation & Submission
  • Labeling & Packaging Material Approval
  • Stability Data & Technical Documentation
  • Renewals & Amendments
  • Coordination with DCGI, CDSCO & State Authorities
  • Response to Regulatory Queries and Notices
  • Compliance with WHO-GMP and Schedule M Protocols

Support for Third-Party Clients

As a Third-Party Manufacturing Aggregator, we assist our clients by providing:

  • Product permission documentation
  • Composition approvals
  • Certificate of Analysis (CoA), Batch Manufacturing Records (BMR), and testing reports
  • Guidance in preparing dossiers and artwork for regulatory clearance

This allows our clients to focus on marketing and distribution, while we manage the compliance lifecycle end-to-end.

Ongoing Compliance Culture

We actively invest in:

  • Regulatory team training & development
  • SOP and document revision based on latest CDSCO updates
  • Regular audits and inspections by internal & external agencies
  • Cross-functional coordination between QA, QC, and production for unified compliance

Certifications & Standards We Follow

  • WHO-GMP Certification
  • DCGI-Compliant Product Licenses
  • CDSCO/State FDA Product Permissions
  • Packaging & Labeling as per Drug Rules
  • Valid Pollution Control, Fire Safety, and EHS documentation

Our Assurance

“We don’t just manufacture quality products—we ensure they’re built and backed by compliance from day one.”
Our Regulatory Affairs team works as a bridge between manufacturing and market access, ensuring that all Aries Drugs products are safe, legal, and launch-ready.