Regulatory Affairs

Regulatory Affairs Services

Right Strategy. Right Market. Right Time.

Strategic regulatory guidance that supports product registrations, variations, renewals, and lifecycle management across multiple regions with clarity and compliance. Our services include regulatory intelligence, dossier preparation, authority interactions, and strategic planning for market entry.

We help you navigate complex regulatory pathways efficiently, ensuring your products reach markets quickly whilst maintaining full compliance with applicable regulations and guidelines.

Dossier Preparation & Submissions

CTD / eCTD dossier preparation and publishing
New Marketing Authorization Applications (MAA)
Variation and change management submissions
Renewal and re-registration submissions
Labeling, artwork, and SmPC / PIL review

Regulatory Strategy & Market Access

Regulatory strategy for new registrations, variations, and renewals
Market entry and country selection planning
Product classification and regulatory status determination
Post-Approval & Lifecycle Management

Health Authority Liaison

Liaison and correspondence with regulatory authorities
Regulatory query tracking and resolution
Support during authority inspections and audits

Regulatory Intelligence

Regulatory intelligence monitoring and impact assessment
Regulatory SOPs and governance frameworks
Regulatory information management (RIM) support
Training, workshops, and advisory services

Our Services

Contact Us

  • B04-332, Business Center 03, RAKEZ Business Zone-FZ,
    Ras Al Khaimah, UAE
  • +971 55 895 5849
  • info@yashfin.net
    info@yashfinpharma.com

Our Brochures

Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.

Download Brochure