MEDICAL DEVICE, BIOLOGICS, DRUGS, AND COMBINATION PRODUCTS – USING OUR EXPERIENCE TO SIMPLIFY COMPLEX REGULATORY OPPORTUNITIES FOR YOU.
ARCHITECTS OF REGULATORY SCIENCE, QUALITY SYSTEMS,
AND CLINICAL AFFAIRS WORK PRODUCTS
Canopy Regulatory Solutions, Inc. (Canopy Regulatory) is a consulting firm specializing in the regulatory science, quality systems, and clinical affairs knowledge needed to efficiently bring your products to market. We work in the medical device, drug, and biologic industry space to develop pre- and post-marketing strategies, work products and applications. We also create hybrid regulatory compliance strategies for novel and combination product lifecycle.
BRINGING PRODUCTS TO MARKET IN
A CHALLENGING ENVIRONMENT
Why use Canopy? We bring both knowledge and practical help.
- You have a product idea in development—but you don’t know how to interpret the regulations and bring it to the finish line.
- You are looking for a way to creatively and competently interact with the FDA or international regulatory agencies, and you need a clear pathway to market.
- You have too much work and need a resource to fill the gaps, use your internal processes, and apply the regulations appropriately.
THE CANOPY DIFFERENCE: WHAT WE BRING TO THE TABLE
EXPERIENCE
With more than 30 years of experience navigating global regulatory, quality, audits, and clinical studies, we have the expertise and know-how needed to streamline and facilitate your product development.
NOVEL APPROACHES
Our experience makes us uniquely positioned to understand conflicting global requirements, legacy products issues, and combination products with challenging compliance regulations and find solutions that meet the company goals.
NOVEL APPROACHES
Our experience makes us uniquely positioned to understand conflicting global requirements, legacy products issues, and combination products with challenging compliance regulations and find solutions that meet the company goals.
PROCESS
There’s a process for everything we do. Like an architect, using a methodical system for designing and building a structure is essential for success. Bringing medical products to market is no different – and we know the blueprint to follow.
PERFECT FOR:
STARTUPS
Bringing your first product to market with minimal or no experience.
ESTABLISHED COMPANIES
Looking for the best strategies and fastest paths to bring new products to market.
ESTABLISHED COMPANIES
Looking for the best strategies and fastest paths to bring new products to market.
MULTINATIONAL FIRMS
Adding more resources to get
the work done.
WHETHER YOU’RE NEW OR DEEP-ROOTED,
CANOPY REGULATORY HAS SOLUTIONS FOR YOU.
UNDER THE CANOPY OF EXPERIENCED EXPERTS…
We pride ourselves in the ability to assess business needs in the context of
the current regulatory environment and deliver meaningful, insightful advice.
We bring you:
Practiced professionals
Business and industry knowledge
Insightful advice
Customized strategies