top of page

Regulatory Affairs 

The last step between your product and the market is the often convoluted regulatory process to demonstrate adherence to quality assurance protocols. Let us help you navigate the regulatory landscape specific to your product in the relevant regions, and efficiently submit the necessary paperwork. 

 

For pharmaceuticals and medical devices, the process is far more strenuous and requires deliberate planning. Frankly, the bulk of your financing will go towards trials. We will help you maneuver through this anticipatory period in your business by identifying the right CRO partners and managing your ongoing interactions with key regulatory bodies such as the FDA and Health Canada. 

1

Clinical Trials & Other Medical Requirement 

Creating your Clinical Trials framework to align with your proprietary strategy. Connecting you with the right CRO partner appropriate for your Phase and unique pharmaceutical, treatment, procedure or medical device. Helping you monitor international branches of Clinical Trials. Working alongside your team to compose and submit the Clinical Trials Protocol to regulatory bodies (FDA, Health Canada, EMA, etc.). 

2

Product-Specific Certifications 

Preparing your product for the market in North America:

  • Fulfilling product-specific customs requirements 

  • Fulfilling product-specific certifications in compliance with the USDA and CFIA for all agriculture and food-related products. 

  • Fulfilling industry-specific regulatory and quality assurance requirements, depending on the product type and location. 
     

3

Ancillary Certifications 

Fulfilling additional certifications to improve product compatibility with broader markets, such as Certified Organic and Certified Halal certifications for agricultural and food products. 

Food_and_Drug_Administration_logo.svg.png
health-canada-logo-vector.png
Logo_standard.jpg
Logo_of_the_United_States_Department_of_Agriculture.svg.png
RT_OrganicFourColorOrganicSeal.jpg
Organic-logo.png
HAG-Symbol-Green.webp
Mountain Lake_edited.jpg

Get in Touch

Send us an email at info@purley-consulting.com

or submit a contact form here.

bottom of page