Regulatory Services at Affordable Prices

QRS is a service of Crystalline Solutions helping manufacturers expand their market.

Don't overpay for Regulatory Advice.

Domestic and Off Shore regulatory Agent services for registration with the FDA, Health Canada and the Austalian TGA - $159 per year (plus any government fees)

Drug Master File (DMF) preparation and maintenance - $489 each, $89 per access letter

Third party FDA equivalent cGMP Facility Certification - $1600 plus travel expense

Regulatory Retainer Services - $29 per communication
Food Facility Registration - $199 one time
Prior Notice Service - $59 each shipment

Prices in USD - wire transfers accepted


Regulatory registration is a mandatory requirement to successfully sell your USP/NF/cGMP ingredients or packaging materials in the Pharmaceutical, Nutraceutical and Cosmeceutical markets.  QRS offers a quick and simple registration process to gain access to three major markets - Canada, Australia and the USA.  

QRS has over 20 years experience in regulatory registrations in these three major world markets.

Quality Resource Services will:

• Act as your Agent and point of contact for all correspondance with the FDA, Health Canada and the Australian TGA
• Prepare, Submit and Maintain your Health Canada Type II Drug Master File (packaging registration) or Type III Drug Master File (non-active ingredient registration)
• Register your company with the Australian TGA
• Register your Proprietory Ingredients (ARTG No) with the TGA
• Prepare, Submit and Maintain your FDA Type IV Drug Master File (non-active ingredient registration)
• Prepare, Submit and Maintain your FDA Type III Drug Master File (packaging material registration)
• Provide all Letters of Authorization to your customers and the regulatory authorities
• Prepare and Provide your customers with a Certificate of Registration
• Register your food facility
• Prepare incoming shipment Prior Notice