Our Services
Regulatory Services | FDA Auditing | Clinical Trial Services
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.
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 - 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 provides regulatory consultation and quality assurance services to companies regulated by the US FDA, EMA, and similar agencies in other countries.
Our major regulatory consulting services include:
- Product Development Strategy
- US FDA Compliance
- Quality Assurance and Quality Control
- US Authorized Agent Services:
- European Medicines Agency (EMA) Compliance
- Pharmacovigilance & Clinical Trials
FDA Regulations for importing and exporting medical devices
Managing a clinical trial project
Clinical trials and their quality standards
Drug Product Life Cycle Management – Automating Clinical Trial Project
Why choose FDAMAP?
FDAMap is a global CRO with extensive experience performing clinical trials. Clinical trial experts – help you get the most out of your investment in R&D.
What people say about us
Get inspired by real people who benefited from our services, training & workshops. FDAMAP worked for them, and it can work for you too!
Regulatory Services | FDA Auditing | Clinical Trial Services
FDAMap provides a comprehensive range of FDA services to companies regulated by the US FDA, EMA, and similar agencies.