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Whitney Consulting is a regulatory consulting firm dedicated to the Chinese market.

Since 1994, we have been providing international clients with services in Chinese medical device regulatory affairs, clinical affairs, and medical market research. From our offices in the United States and China, we bring clients up-to-date information on regulations, in-depth technical expertise, first-hand experience, and practical strategic pathways in the fast-growing and challenging Chinese market.

Dedicated to the Chinese Medical Device Market, Chinese Regulatory Affairs and Chinese Market Research since 1994

Bilingual Staff who can provide services within China or the rest of the World, adhering to these principles of auditing:

  • Integrity
  • Fair Presentation
  • Due Professional Care
  • Confidentiality
  • Independence
  • Evidence Based Approach
  • Risk Based Approach
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Your China Regulatory Team

Areas of Expertise

SERVICES:

  • Regulatory affairs for medical device and IVD
  • Clinical affairs for medical device and IVD
  • Regulatory strategy and pathways
  • Post market surveillance, reporting, and mediation
  • Market intelligence Research and practices
  • Quality Management System (QMS) audit services

SPECIALTIES:

  • Biomaterial, animal derived material
  • Cardiac and vascular
  • Dental implant material
  • In-Vitro Diagnostics
  • Medical imaging
  • Orthopedics
  • Respiratory
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Why Choose Us

  • Values and ethics: “Do the right thing when no one is watching.”
  • Confidentiality: Your secret is safe with us.
  • Anti-bribery and anti-corruption: No under-the-table deals.
  • History: More than 20 years in China.
  • Reputation: Known for our China expertise.
  • Experience: Broad spectrum of products and applications.
  • Constant contact with regulators: Daily and weekly check-ins.
  • Continuing education: Training is important.
  • Collaborative and supportive work force: Team work!
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Our Strengths

  • In-depth understanding of the regulations and their implications
  • Fast access to news and policies
  • Effective project management
  • Skillful communication with regulators, reviewers, test engineers and others
  • Attention to detail
  • Team work approach to issues
  • Scientific minds and logical thinking
  • Language proficiency in both English and Chinese
  • An understanding of both Chinese thinking AND Western thinking
  • Established business structure and network of partners to support a full range of services
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Our Expertise

NMPA Product Registration

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Man at meeting reviewing on a laptop

Regulatory Strategy

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business people discussing strategy with laptops

Post-Market Surveillance

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surgery in an operating room

Clinical Trials

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Scientist working with clinical study