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.

ABOUT US

OUR GLOBAL SERVICES INCLUDE:

Regulatory Science

REGULATORY SCIENCE

Regulatory Operations

REGULATORY OPERATIONS

Quality Systems

QUALITY
SYSTEMS

Clinical Affairs

CLINICAL
AFFAIRS

Training

TRAINING

EXPLORE SERVICES

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

regulatory science quality systems clinical affairs consulting

LET’S TALK.
GET IN TOUCH TODAY, AND LET’S DISCUSS
YOUR NEEDS AND HOW WE CAN HELP.

CONTACT US TODAY