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
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FDA Agent
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Health Canada Agent
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TGA (Australia) Client Restiration
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TGA Propriatary Ingredient Listing
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FDA Facility Registration
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Health Canada Facility Registration
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FDA Type IV Drug Master File
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Health Canada Type 3 Drug Master File
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Vendor cGMP Questionnaire Service
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Regulatory Consultant Service
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Food Facility Prior Notice
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Third Partys GMP Facility Audit
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GMP Training
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FDA Pre-Audit Preparation Service
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Medical Device Listing
Start today by contacting us for further information or clicking the Agent Services tab.