Comprehensive Regulatory Services

End-to-end regulatory solutions for pharmaceutical and nutraceutical products worldwide

Our Regulatory Services

Dossier Preparation & Submission

Complete regulatory dossier preparation services meeting global regulatory agency requirements. We ensure compliance with specific formats and guidelines for each target market.

  • Common Technical Document (CTD) - For US, EU, Canada, Japan and other ICH regions
  • ASEAN Common Technical Document (ACTD) - For ASEAN member countries
  • Electronic CTD (eCTD) - For electronic submissions to FDA, EMA and other agencies
  • Country-specific formats - Customized for specific regulatory requirements

Key Benefits

  • Faster dossier preparation
  • 100% compliance with agency requirements
  • Dedicated regulatory specialist
  • Real-time progress tracking

Variation Filing & Lifecycle Management

Comprehensive variation filing services for post-approval changes throughout the product lifecycle. We manage all types of variations to ensure continuous compliance.

  • Type IA Variations - Minor variations requiring notification
  • Type IB Variations - Minor variations requiring approval
  • Type II Variations - Major variations requiring extensive documentation
  • Extension Applications - For new indications, strengths, or routes of administration

Our Approach

  • Regulatory impact assessment
  • Document preparation and compilation
  • Agency submission and follow-up
  • Post-approval compliance monitoring

Regulatory Query Management

Expert handling of regulatory queries and information requests from health authorities to prevent approval delays.

  • Rapid response preparation
  • Scientific justification support
  • Meeting preparation with agencies

Artwork Review & Approval

Comprehensive review of packaging artwork and labeling materials to ensure regulatory compliance across markets.

  • Label content verification
  • Packaging material review
  • Country-specific requirements

DMF Preparation & Maintenance

Preparation and maintenance of Drug Master Files (DMF) for Active Pharmaceutical Ingredients (APIs).

Open Part DMF preparation
Annual reporting
Update management

Our Regulatory Process

1

Initial Assessment

Comprehensive review of your product and regulatory requirements

2

Strategy Development

Customized regulatory strategy for target markets

3

Dossier Preparation

Compilation of complete regulatory dossier

4

Submission & Follow-up

Agency submission and response management

5

Approval & Maintenance

Post-approval support and lifecycle management

Need Expert Regulatory Support?

Contact us to discuss your specific regulatory requirements and get a customized solution for your products.

Schedule a Consultation