Regulatory & Licensing Data

Regulatory & Licensing Intelligence

Access internationally verified regulatory and licensing data across the pharmaceutical sector and related industries.

Our platform provides detailed insights into national authorities, responsible officers, registration pathways, and product authorization requirements in key global markets. Explore licensing timelines, document templates, CPP and GMP requirements, and submission procedures to streamline product registration and market entry. With continuously updated regulatory intelligence, you can ensure compliance with evolving standards, minimize approval delays, and make data-backed decisions for efficient licensing and expansion.

Pharmaceutical Products

  • Product registration and marketing authorization support
  • Preparation and review of CTD/ACTD dossiers
  • GMP, CPP, and Manufacturing License verification
  • Variation, renewal, and re-registration tracking
  • Import/export permit data and regulatory timelines
  • Local regulatory authority contact and submission procedures
  • Data on pharmacovigilance and post-marketing reporting requirements

Cosmetics & Dermocosmetics

  • Product notification and safety assessment data
  • Preparation of Product Information File (PIF) and labeling compliance
  • CPNP (EU) and regional cosmetic registration procedures
  • Ingredient restriction and banned substance monitoring
  • Good Manufacturing Practice (ISO 22716) certification data
  • Market claim substantiation and testing requirements

Medical Devices

  • Device classification (Class I, IIa, IIb, III) and conformity assessment routes
  • CE marking and ISO 13485 compliance data
  • Regulatory documentation requirements (DoC, GMDN, UDI, technical file)
  • Importer/distributor authorization and vigilance reporting obligations
  • Device registration timelines and authority-specific checklists

Food Supplements & Nutraceuticals

  • Regulatory frameworks for registration and labeling
  • Ingredient and additive approval lists per region
  • Health claim regulations and EFSA/FDA guidance data
  • Manufacturing and export license requirements
  • Cross-border compliance for GCC, CIS, and EU markets

Herbal & Traditional Products

  • Traditional herbal registration requirements (THMPD, WHO guidelines)
  • Data on monographs, safety documentation, and botanical standardization
  • Labeling and packaging compliance by region
  • Import/export licensing and phytosanitary certification procedures
  • Pharmacopoeia references and regulatory classifications

Key Benefits

Global Coverage

Comprehensive regulatory data across key global markets and regions.

Compliance Assurance

Ensure adherence to evolving regulatory standards and requirements.

Time Efficiency

Minimize approval delays with accurate timelines and procedures.

Continuous Updates

Stay current with evolving regulatory standards and requirements.

We employ multiple verification methods including direct communication with regulatory authorities, cross-referencing official government databases, validation through legal representatives in each jurisdiction, and continuous monitoring of regulatory updates and changes to ensure data accuracy and reliability.

Yes, our platform covers both established and emerging markets including GCC countries, CIS nations, Southeast Asia, Latin America, and African regions. We provide specific regulatory requirements, local authority contacts, and cultural considerations for each market to support successful market entry.

Our regulatory intelligence is continuously updated with real-time monitoring of regulatory changes, authority announcements, and legislative updates. We provide immediate notifications for critical changes and comprehensive quarterly reviews to ensure you always have access to current regulatory requirements.

Absolutely. Our platform includes access to standardized document templates, submission checklists, procedural guidelines, and authority-specific requirements. We also provide guidance on document preparation, formatting requirements, and common submission pitfalls to avoid.

Yes, we cover comprehensive regulatory requirements across multiple product categories including pharmaceuticals, cosmetics, medical devices, food supplements, nutraceuticals, herbal products, and traditional medicines. Each category has specialized regulatory pathways and our platform provides category-specific guidance and requirements.
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