International Consultants for US FDA Approval, ISO Certification, CE Mark and Regulatory Affairs

International regulatory consulting services for companies based in North America (US and Canada), Asia (China, Japan, India, South Korea and Singapore) and Europe (EU countries emphasizing Germany, France and the UK). Selected companies in the directory may serve as United Sates Food and Drug Administration (FDA) Authorized Representatives, US Agents, Official Correspondents for international medical device manufacturers and pharmaceutical, drug and alternative medicine companies seeking to enter the US market. Consulting for American firms with the regulatory requirements necessary to enter foreign markets.

General International Consulting Services Offered:

  • For US Clients: A wide range of regulatory and business assistance for US-based medical device and pharmaceutical/drug Manufacturers including ISO Certification, CE Marking, FDA Medical Device/Pharmaceutical regulatory process consulting.
  • For Foreign Clients: Authorized Representatives, US Agents and Official Correspondents with the FDA for offshore medical device manufacturers
    • Asia: Serving Asian medical device firms – primarily Chinese, Indian, Japanese, Korean and Malaysian medical device manufacturing companies
    • Europe: Serving EU/European companies – mainly German, French, Swiss and British/English medical device and pharmaceutical manufacturers

Worldwide Distribution

Establishing worldwide distribution networks for domestic medical products sold throughout Europe, Asia and North America

  • Asia: Distribution throughout the Pacific Rim and East Asia including China (PRC), Hong Kong, Japan (Tokyo), India, Taiwan, South Korea, Singapore, Malaysia and The Philippines
  • Europe: Distributors covering mainly Western Europe/EU countries especially Germany, France, Switzerland, Italy, Spain, Norway, Sweden, Finland and the UK
  • North America: Sales, Marketing and Distribution in Canada, Mexico and the United States. Distribution in the US West Coast, Midwest, South, East Coast and Northeast regions emphasizing Washington DC, New York, North Carolina, Southern/Northern California, New Jersey, Florida, Illinois, Ohio, Pennsylvania and Texas.
  • Other: Limited International assistance in South America (mainly Brazil and Argentina), The Middle East (Israel, Egypt, Jordan and Saudi Arabia) and the Caribbean (Puerto Rico and Dominican Republic).

Regulatory Affairs for Overseas Clients

Consulting to attain FDA approval of foreign medical devices for sale in the US and implementation of ISO International Standards for foreign and domestic companies

  • FDA Regulatory Compliance
  • CE Mark/EU Regulatory compliance
  • Summary Technical Documentation
  • Global Medical Device Nomenclature (GMDN)
  • Quality Management Systems
  • ISO Quality Systems Implementation (ISO 13485, ISO 9001:2000 and ISO 13488:2000)
  • 21 CFR Part 11 Compliance
  • GMP Compliance
  • Class II Medical Device 510(k) Approvals (Class I & Class III approvals as well)

Business Services

  • Strategic Marketing and Business Strategy
  • US-Domestic and Overseas Funding/Investment
  • International Marketing/Market Research Assistance
  • Worldwide Distribution and Sales
  • US Customs Brokers Assistance
  • Multinational Corporate Licensing and OEM Agreements
  • Product Registration and Reimbursement Consulting
  • US and Foreign Document Translation Services: Technical Writing and English Language Translation to/from Chinese (Mandarin/Putonghua and Cantonese/Yue), Japanese (Nihongo), Filipino (Tagalog), Spanish (Espanol), French (Francais) and German (Deutsch)

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