The FDA approval process is the Gold Standard for health care product approval.

We know the system ‘inside out’ and how to make it work for your project.

Regulatory Affairs Associates optimizes efficiency with a team of highly experienced experts.

Our clients are delighted by our :

• Quick response
• Attention to detail
• Cost effective work
• Unsurpassed results in Drug and Medical Device approval

Shouldn’t you call for a fast, informal discussion to see how we can take

your project through the FDA approval process ?

We also deliver results for your projects outside of the US.

We make sense out of the alphabet soup of global rules and regulations:

• Import

• Export

• Labels

• Approvals

• Shipping

• Postmarketing requirements

This FDA consultant group applies over 35 years of experience

in a dynamic process that has delivered quality results

for large and small clients.

~Agile minds that seek solutions

~Clarity of work

~Fantastic attention to detail

~A group of dedicated experts

Working to provide you with excellent service

Our project solutions will exceed your expectations.

The FDA approval process often relies on :

• Pharmaceutical import knowledge

• In depth experience with FDA clinical trials

• Toxicology and biocompatibility

We can direct, manage, or audit all these activities

to expand your company’s expertise and achieve

the project objectives.

We can even direct you to information on cancer treatment.

SUCCESS IN THE FDA APPROVAL PROCESS IS OUR EXPERTISE

Why don’t you call today to find out how we can help ? . . . 248 747 8008

Ask for Steve Goldner. He will help you. sgoldner@regaffairs.net