Accelerating Clinical Success with Proven Innovation and Expertise.

Through 20+ years running successful trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

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What we do

A full-service, global CRO with extensive experience performing clinical trials. We provide efficient solutions to the most demanding challenges, focused on completing projects on time, on budget and with the quality that withstands vigorous scrutiny.

Regulatory Services

We provide regulatory consultation and quality assurance services to companies regulated by the US FDA, EMA and similar agencies in other countries.   

FDA Auditing

We help train drug and device manufacturers in FDA audit preparation and conduct mock FDA audit at their premises.   

Quality Assurance

We provide comprehensive range of quality assurance and regulatory GxP compliance services to the pharmaceutical, medical device, biotechnology, dietary supplement and other FDA-regulated industries

Clinical Trial

We provide a comprehensive range of clinical trial, site certification and patient recruitment services.      

Project Management

Our qualified project managers and experienced consultants provide regulatory information and quality assurance for successful project outcomes.

Training & Workshops

We help accomplish regulatory and compliance objectives of companies with our customized FDA training programs and one-on-one consultation

FDAMap is a group of experts in healthcare and food regulations, business, and public policy in the US, Europe, Asia, South America, and most other parts of the World.

FDAMAP – Our Passion

FDAMap - Experts in Healthcare and Food Regulations, Business, and Public Policy

We strive to create awareness, education, professionalism, and success in all areas of compliance, quality, and project management. We follow the following Principles that define our culture and shape

Accountability

Hold oneself and others accountable; own the outcomes

Client Service

Delivering quality, creativity, innovation, and value to every client every day; clients as partners

Mutual Respect

Act with integrity; lead by example; communicate candidly

FDA Regulatory Consulting

FDAMap helps you complete your trials on budget and on time, with one-stop, in-house service offerings.
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FDA Regulations for importing and exporting medical devices

Managing Clinical Trials
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Managing a clinical trial project

FDAMAP - Clinical Trails and their quality standards
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Clinical trials and their quality standards

FDAMAP - Drug Product life cycle Management
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Drug Product Life Cycle Management – Automating Clinical Trial Project

Why choose FDAMap?

FDAMap is a global CRO helping you get the most out of your investment in R&D with our group of regulatory and clinical trial experts.

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Years Of Expertise
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Trials
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What People Say About Us

“Very engaged and helpful instructor. Mr. Kumar made the course very comfortable and open. Most useful to beginners and some tips for advanced users.”
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Medical writer
Abbvie
“I attended the FDA Audits and FDA Meetings workshop and found it very interesting. The content surpassed my expectations. I hope to attend the GLP workshop in July.”
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Laboratory Project Manager
Argentine Company
“Dr Mukesh Kumar's content was solid. Very useful for new regulatory professionals and new technical writers. Answered all of my questions.”
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Senior Regulatory Manager
Medtronics

Driving Breakthroughs in Clinical Development with Expert Precision

FDAMap provides a comprehensive range of FDA services to companies regulated by the US FDA, EMA, and similar agencies.