Industrial Services

Industrial Services

• Strategic Planning and Business Growth Consultation


• R&D Services 


• QMS and Pre-audit Services 


• Local and Global Regulatory 

  • FDA 510(k) Regulatory Compliance for Medical Devices:
  • Determine Device Classification
  • Conduct Predicate Device Comparison
  • Compile Documentation
  • Submit to FDA
  • FDA Review and Clearance
  
  
  • Over-The-Counter (OTC) Drug Approvals:
  • Drug Listing
  • OTC Monograph Compliance
  • Labeling and Marketing Compliance
  
  
  • Cosmetics Regulatory Compliance
  • product Assessment
  • Labeling Compliance


• Industrial EU, US & GCC Exportation Services

  • Creation or Review of Product Information File (PIF): Ensuring compliance with European Union requirements.
  • Review of Product Composition and Packaging Design: Verification of alignment with European Union standards.
  • Facilitating Necessary Tests and Certificates: Obtaining safety certificates and conducting required tests in certified European Union laboratories.
  • Responsible Person (RP) Services: Essential for product approval and trading in European Union countries.
  • Product Registration on European Union Platform: Securing the necessary Notification number (CPNP) for product trading.