Specialization to Meet Industry Demands 

PHDS Consulting, in addition to the breadth of consulting expertise highlighted above, has experienced teams with specialized expertise to help clients successfully navigate challenges and realize opportunities. 

Our consultants leverage our unique vantage point, one have gleaned from over 20 years experiences in drug and biologic development and commercialization in China to refine drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. 

Biotechnology, pharmaceutical and diagnostic/medical device companies can take huge advantage of our development strategy and experience with regulatory administration in China. PHDS provides comprehensive regulatory guidance and/or specialized consulting services. 

We offer you the ability to put ideas into action to help you:

l       improve operational efficiency and outcomes

l       optimize pipeline value and ROI

l       improve regulatory compliance

l       hedge risk and reduce infrastructure costs 

Product Development Consulting

With a long history of consulting in a wide range of therapeutic areas, our consultants have broad professional knowledge and an in-depth understanding of regulatory guidelines in China. PHDS provides medical therapeutic area, regulatory and biostatistical consulting on a wide variety of product development and pharmaceutical development issues in all major therapeutic areas. PHDS also has extensive expertise in the development of pharmaceutical products, as well as in the development and approval of medical devices.

Our Wins are Yours: Successful Regulatory Submissions in China

PHDS has secured hundreds of licenses and approvals for our clients, including:

l       Investigational new drug applications (INDs) for clinical trials

l       Clinical trials applications (CTAs) and new drug applications (NDAs) for imported products

l         Licenses for medical devices, health food, function food, drug packaging materials, novel food, functional food/health supplements (blue hat), disinfectants and cosmetics, etc.