FDA Map

FDA Map

Business-Consulting-and-Services

Maryland, maryland
Website
Company Tagline

CRO and Regulatory Expertise

Industry Category
Business-Consulting-and-Services
Company Description

FDA Map is a leading global consulting and training organization specializing in FDA and international regulatory affairs, clinical research, and product development strategy. With a rich history spanning over two decades, FDA Map has consistently guided numerous biotechnology, pharmaceutical, and medical device companies toward successfully bringing safe, effective, and compliant products to market. FDA Map's unwavering commitment to excellence has solidified its reputation as a trusted partner in navigating the intricate regulatory landscape. The primary address for FDA Map is Maryland, maryland, US.

FDA Map offers a comprehensive suite of core services designed to empower innovators and streamline compliance pathways. These services include FDA & EMA regulatory submissions (IND, BLA, NDA, 510(k)), clinical trial design, monitoring, and compliance, GMP, GCP, and GDP audits and training, global regulatory education and workshops, and market entry strategies for the U.S. and Latin America. FDA Map's holistic approach ensures that clients receive tailored solutions that address their specific needs and challenges.

Driven by a visionary approach, FDA Map aims to bridge the gap between science, innovation, and regulation, ensuring that groundbreaking ideas reach patients faster, safer, and smarter. FDA Map is dedicated to empowering innovators and fostering a future where scientific advancements translate into tangible benefits for global healthcare. The information provided will be completed soon with the support of the company’s management. We invite the manager of FDA Map to create a customized and exclusive company showcase and product listing on our platform.

Key Personnel / Employees
Mukesh Kumar PhD RAC

Compare Companies Side by Side

Compare FDA Map with 3 companies in Business-Consulting-and-Services

4 Companies
Comparison Field
FDA Map
FDA Map
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Founded Year
1977 2008 1989
Company Size
2-10 1 employee 1,001-5,000
City
Maryland, maryland Ipswich, Suffolk Camarillo, CA Hamburg, Hamburg
Country
United Kingdom United States Germany
Skills & Keywords Comparing with main company
31 Total Skills
FDA Regulatory Affairs Clinical Research Product Development Strategy Regulatory Submissions GMP Compliance GCP Audits Market Entry Strategies Clinical PM IDE Cosmetics FDA Registration EOP2 GMP Medical Foods HCTPs CRO FDA Meetings 510k BLA GLP QA GCLP GCP ANDA US Agent IND GAP Analysis Pre-NDA Audits GACP Dietery Supplements
29 Total 29 Unique
Unique Skills:
Animal Health Audit Programmes AVP Booklets Careers Area Computing +23
26 Total 26 Unique
Unique Skills:
21 CFR Part 11 Adverse Events Bioinformatics Cloud Computing Biotechnology & Pharma Business process outsourcing CDER +20
39 Total 39 Unique
Unique Skills:
Agro Chemicals Analytical Services Bioanalysis Bioanalytical Services Bioburden Central Laboratory +33
4
Total Companies
1977
Oldest Founded
3
Countries
124
Unique Skills

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Alternative Company Names

This company is also known as

FDA Map FDA Map (中文) FDA Map (हिंदी) FDA Map (español) FDA Map (العربية) FDA Map (français) FDA Map (русский) FDA Map (português)