Crystalline Solutions
Simple
Affordable
Regulatory Services
Simple and Affordable Regulatory and Registration Help

 

Crystalline Solutions has 20 years in facility registration experience and a broad network of information sources to provide quick solutions to market expansion or regulatory roadblocks.

Off shore or domestic manufacturing sites producing USP, Pharma grade or Food Grade excpients require a point of contact with the FDA, Health Canada or the TGA.  All agency questions and submissions will be handled through our office,  Regulatory support has never been simpler or more affordable.  Click and ask us - we'll give you our price up front.

Services Offered

  • FDA Agent
  • Health Canada Agent
  • TGA (Australia) Client Restiration
  • TGA Propriatary Ingredient Listing
  • FDA Facility Registration
  • Health Canada Facility Registration
  • FDA Type IV Drug Master File
  • Health Canada Type 3 Drug Master File
  • Vendor cGMP Questionnaire Service
  • Regulatory Consultant Service
  • Food Facility Prior Notice
  • Third Partys GMP Facility Audit
  • GMP Training
  • FDA Pre-Audit Preparation Service
  • Medical Device Listing

Start today by contacting us for further information or clicking the Agent Services tab.

 

USA Mailing Address Canadian Mailing Address
3430E Jefferson Ave Suite V4089 554 Greendale Drive
Detroit, Michigan, USA 48207

Windsor, Ontario, Canada N8S 4A8

Toll Free 866 443 6436 Toll Free 866 443 6436
International 001 519 800 0013 International 001 519 800 0013
EFAX 309 405 0268 EFAX 309 405 0268
Email info@crystallinesolutions.com Email info@crystallinesolutions.com