Regulatory Affairs & Global Filings

Strategic regulatory guidance and documentation support for pharmaceuticals, medical devices, cosmetics, cosmeceuticals, and nutraceutical products to facilitate approvals in India and international markets.

Regulatory approval is a critical step in the development and commercialization of healthcare products. SYNTIQ Global provides comprehensive regulatory support to assist organizations in navigating regulatory requirements and preparing compliant submissions for pharmaceuticals, medical devices, cosmetics, cosmeceuticals, and nutraceutical products.

Our regulatory services support submissions aligned with major international authorities including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Central Drugs Standard Control Organization (CDSCO), Therapeutic Goods Administration (TGA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, National Medical Products Administration (NMPA), Health Sciences Authority (HSA), Swissmedic, and other regulatory agencies across global markets.

Our Regulatory Services

Regulatory Strategy & Pre-Submission Planning

• Regulatory pathway assessment and product classification
• Regulatory strategy development for targeted markets
• Regulatory gap analysis and documentation readiness evaluation
• Guidance on regulatory requirements, standards, and compliance frameworks
• Planning and preparation for regulatory submissions

Dossier Preparation & Technical Documentation

• Preparation and compilation of regulatory dossiers and technical files
• Development of technical documentation for product registration
• Compilation and formatting of regulatory documentation in accordance with applicable guidelines
• Labeling review and regulatory documentation verification
• Preparation of supporting technical and regulatory data packages

Regulatory Submission & Global Filings

• Product registration and regulatory filing support across international markets
• Submission coordination with regulatory authorities
• Documentation management and submission package preparation
• Regulatory submission tracking and communication support

Post-Submission & Regulatory Lifecycle Support

• Preparation of responses to regulatory authority queries
• Support for variations, amendments, and regulatory updates
• License renewals and regulatory lifecycle management
• Ongoing regulatory compliance documentation and support

Get in Touch

Consultation Request

Have a regulatory challenge or project in mind?
Share your requirements and our team will respond promptly.

Let's Talk

8903282797

Mail Us

info@syntiqglobal.com