Who are we

Humphries Pharmaceutical Consulting, abbreviated as HPC, is a professional consulting company that provides high-end regulatory services to the pharmaceutical industry. Founded in 2003 in Maryland, USA, and expanding to Nanjing, China, in 2012, HPC has gradually established a service system centered around pharmaceutical regulations, with drug registration, product development and compliance, business development, and project management as its pillars. HPC focuses on the process, commits to results, and works diligently. It accompanies the growth of Chinese pharmaceutical enterprises and contributes its efforts to the internationalization of the Chinese pharmaceutical industry.

20 years

Service

200 number

Number of Clients

10 people

Former FDA/CDE Experts

2400 times

Formal Communications with FDA/CDE

Who Are We

20 years

Service

200 number

Number of Clients

10 people

Former FDA/CDE Experts

2400 times

Formal Communications with FDA/CDE

Service
Regulatory Affairs Regulatory Affairs

Regulatory Affairs

Product Development and Compliance Product Development and Compliance

Product Development and Compliance

Business Development Business Development

Business Development

Regulatory Affairs

More

Humphries Pharmaceutical Consulting (HPC) specializes in the field of pharmaceutical registration and is a pioneer in the registration Contract Research Organization (CRO) industry. We provide pharmaceutical registration services related to the regulatory frameworks in China and the United States.

Regulatory Strategy and Consulting

>Determination of the IPO Path and Milestones

>Development of Declaration Plan and Risk Advisory

>Analysis of Technical Documentation Gaps

>Interpretation and Response to Regulatory Agency Opinions

Preparation and Submission of Regulatory Documents

>IND Application

>NDA/BLA/ANDA

>IND Maintenance

>NMPA Drug Registration

Regulatory Agency Meetings and Communications

>INTERACT and Pre-IND Meetings

>End-of-Phase Meetings

>Pre-NDA/BLA Meetings

>Other Meetings with FDA/NMPA

Special Designations and Accelerated Pathway Applications

>Orphan Drug Designation (ODD)

>Fast Track Designation (FTD)

>Breakthrough Therapy Designation (BTD)

>Regenerative Medicine Advanced Therapy Designation (RMAT)

eCTD Compilation and Submission

>eCTD Compliance Adjustment

>eCTD Assembly, Publishing, and Validation

>eCTD Lifecycle Management

Regulatory Project Management

>Effective Communication

>Time Management

>Document Management

>Meeting Management

Regulatory Affairs

Product Development and Compliance

More

Humphries Pharmaceutical Consulting (HPC) specializes in the field of pharmaceutical registration and is a pioneer in the registration Contract Research Organization (CRO) industry. We provide pharmaceutical registration services related to the regulatory frameworks in China and the United States.

Chemistry, Manufacturing, and Control (CMC)

>CMC Regulatory Consultation and Defect Analysis

>Preparation of Regulatory Submissions

>CMC Regulatory and Technical Training

>Due Diligence for CMC-related Matters

Preclinical Development

>Preclinical Development Strategy

>Preparation of Regulatory Submissions

>Training on Preclinical Studies

Clinical Development

>Clinical Development Strategy and Study Design

>Medical Writing

>Assistance in Clinical Trial Execution

GMP Audit, Consultation, and Inspection

>Quality System Development

>Mock Audits

>Accompanying Audits

Product Development and Compliance

Business Development

More

Since 2015, with the opening of policies and the rapid flow of talents, funds, and technology, the level of technological innovation in the Chinese pharmaceutical industry has been increasing. Business development capabilities have also become more mature. From the early stages of simple licensing in, companies have gradually shifted to a combination of licensing in and licensing out, allowing them to quickly enter the market or secure financing through fast-follow strategies. Chinese pharmaceutical enterprises are making full use of the high-profit margins in foreign markets and the cost-effectiveness of domestic research and development, continuously optimizing their ecosystems. However, due to the relatively short duration of this internationalization development transformation and limited accumulated experience, various challenges are inevitably encountered in the process. Humphries utilizes its professional expertise to assist the pharmaceutical industry in navigating the complexities of business development and avoiding common pitfalls.

Business Development
Resource
Regulations
More
Contact Us

China Office

400-096-2698

hpc@humphriespcc.com

Room 602, 6th Floor, Ping An Financial Center, No. 189 Hanzhong Road, Qinhuai District, Nanjing, China

United States Office

1-301-637-7737

hpc@humphriespcc.com

10411 Motor City Drive, Suite 750, Bethesda, MD 20817, USA