US, China, EU and Japan FDA Regulatory Consultants in Orange County, Southern California

FDA/ISO Regulatory Affairs Consultants

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Authorized Representatives, US Agents and Official Correspondents with the FDA. FDA Advisors, RAC certified regulatory affairs professionals (RA/RAC), Regulatory Consultancy, US Agents, Correspondents and US Representatives

US Federal Agency consulting for EU (Germany, UK, France), Mexico, South America (Argentina, Brazil) and Asia (China, Japan, India, Taiwan and Singapore)

California, Oregon, Arizona, Ohio, Illinois, New York, Washington DC, Connecticut, Pennsylvania, New Jersey, Texas, Florida and South/North Carolina State Regulations

Southern California: San Diego, Orange County, Los Angeles (LA) and Northern California CA: San Jose and San Francisco

ISO, FDA, EU-CE, MDD (Medical Device Directives), UL and CSA regulatory affairs consultants and consulting services

ISO 13485, ISO 9001 certification, registration and notified body contact. FDA and ISO Regulatory Affairs Consultants for FDA regulated products, ISO/EU/CE certification, registration and compliance

AREAS OF EXPERTISE

FDA 510k

PMA • NDA

Quality•GMP•ISO•CE/EU MDD

Supplements•Botanicals

Lab Testing•Clinical Trials

Risk Management

International

State Regulations

Business Start-ups

LOCATIONS

Regional Offerings – California, US, China, EU...

California: Offering local service and both federal and state regulatory consulting to medical device manufacturers and pharmaceutical companies in Southern and Northern California (CA), primarily San Diego, Orange County, Los Angeles (LA), San Jose and San Francisco

USA: Offering services for customers throughout the West Coast (CA, WA, OR, AZ) and some Midwest (OH, IL), East Coast (NY, NJ, CT, PA) and South West/South East (TX, FL, NC, SC) locations

International: Offering international consulting services in Europe (EU nations, primarily Germany, UK and France), Asia (including Japan, India, Taiwan and Singapore), with frequent visits to China, primarily Shanghai, Beijing, Guangzhou, Shenzhen and Hong Kong.

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