FDAMap is a group of experts in healthcare regulations, business, and public policy in the US, Europe, Asia, South America, and most other parts of the World with a collective experience of decades in each area. We strive to create awareness, education, professionalism, and success in all areas of compliance and quality.

1. FDAMAP
Making Regulations Easy….
Workshops, Boot-camps and
Conferences
A one stop source for training, education, and consultation
about US FDA processes.
www.FDAMap.com
Email: Info@FDAMap.com
410-501-5777
20203 Goshen Rd, Suite 261
Gaithersburg, MD 20879

2. WHO WE ARE
FDAMap is a group of experts in healthcare
regulations, business, and public policy in the US,
Europe, Asia, South America, and most other parts of
the World with a collective experience of decades in
each area. We strive to create awareness, education,
professionalism, and success in all areas of
compliance and quality.
We work with professionals, regulators, and
government agencies to build unique platforms for
consultation, training, networking, and professional
development. We strive hard to make high quality,
mutually beneficial relationships with our customers
and partners alike.

3. SIMPLIFYING THINGS FOR YOU…
We keep things simple and straight-forward, give
equal attention to praise and criticism both, so that
we continue doing the things meticulously we do well
and improve where required. We aim to build better
platforms for interactions for experts and novices,
alike, enabling them to come together to learn,
contribute, and make a difference.

4. OUR HISTORY
We started about 16 years ago in the Washington DC
metropolitan area as a consulting enterprise and
grew over the years to create first of its kind
consultation portals. The FDAMap initiative is the
newest venture of a group of leading experts from the
industry and government to bring professionals at all
levels together to create best practices based on
logic, logistics, legal, and least-burdensome
compliance.

5. OUR PANEL OF EXPERTS
IN THE UPCOMING CONFERENCE IN ZÜRICH
Our panel of experts and speakers comprise of distinguished industry professionals,
who are well known across the US and Europe for their expertise in regulatory strategy,
pharma, compliance, GMP and quality issues.

6. OUR SPECIALIZATION
THOUGH WE SPECIALIZE AT MANY THINGS, BUT WE HAVE ACQUIRED GLOBAL
REPUTATION FOR REGULATORY AND COMPLIANCE ISSUES, CLINICAL TRIALS, SEEKING
CONSULTATIONS AND PROVIDING EXPERT ADVICE FOR PHARMA PROFESSIONALS AND
MANUFACTURERS.
Interactions with US
FDA, Health Canada,
EMA, Notified Bodies,
KFDA, CFDA, and TGA,
FDA meeting process,
how to prepare for
meetings with the
FDA.
CURRENT GUIDELINES
and from Healthcare
regulatory agencies
Expert Advice,
regulatory affairs and
compliance training,
regulatory
compliance
consulting, and
regulatory strategy for
medical products.

7. OUR UPCOMING CONFERENCE
Regulatory Consultations –
Effective Interactions with
US FDA in Comparison to
European Authorities to
Accelerate Global Drug
Development
Regulatory Strategy Summit-I
28-29 May 2015, Zurich, Switzerland

8. WHY YOU NEED TO ATTEND THIS CONFERENCE
 It’s an opportunity to learn the agency’s perspectives on how to
properly interact and what their expectations are during
teleconferences and meetings
 The speakers will provide examples and case studies of best practices
as well as common pitfalls in industry-agency interactions resulting in
delays and denials
 Our panel of speakers includes experts, who are familiar with regulators’
perspective on adequate meetings
 Encapsulated information at one place
 Step-by-step instructions on creating a meeting-information-package /
briefing book

10. We organize seminars and workshop for
Drugs, biologics, medical
devices and diagnostic kits
developers, who are
planning to meet
regulators or need tips on
how to get the most out of
a meeting with regulators.

11. www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg,
MD 20879
Email: info@FDAMap.com | Phone: 410-501-5777 | (C)
Copyright (2015) All Rights Reserved
For more information about our
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