Our Knowledge and Experience are Yours

China represents a tremendous growth opportunity for biopharmaceutical clients, yet the country’s evolving regulatory environment can pose significant hurdles for product development.

PHDS is the ideal partner to help you ensure your medicinal product’s success from discovery through post-approval.

With more than 20 years’ experience, PHDS brings diverse expertise across therapeutic areas and functional disciplines to provide biopharmaceutical consulting services throughout the product life cycle. Our experts work closely with you to develop customized plans that increase efficiency and reduce risk to help you realize your product’s value.

Our regulatory consulting services include:  

· Scientific advice

· Competitive intelligence surveys

· Regulatory strategy definition

· Feasibility and strategic consultation

· Clinical trial applications, maintenance and trial support

· Pharmacovigilance processes

· Marketing applications

·  Launch and post-approval activities 

Expert Consultation and Comprehensive Regulatory Support

PHDS brings more than 20 years of focused regulatory affairs experience in China. Comprehensive regulatory services for medical devices, health food, function food, drug packaging materials, novel food, functional food/health supplements (blue hat), disinfectants and cosmetics, covering:

· IND/NDA submissions  

· Variations and renewals

· Regular engagements with the Chinese regulatory agency, the National Medical Products Administration (NMPA) to keep you informed of regulatory changes

· Marketing applications

· GMP implementation and auditing