Beijing, China

Email:

customer@cnphds.com

Phone:

+86-10-84466227

+86-10-84466228

+86-10-84466229

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Service

Trust in the Leading CRO in China

PHDS brings more than 20 years of experience in China and a reputation as a preeminent contract research organization (CRO) in China to help you navigate the evolving Chinese regulatory landscape and get your products into China faster. We offer a full spectrum of supports to you, including regulatory submission and management, regulatory consulting and intelligence, medical writing and quality review -- everything is available to you from our one-stop service. We leverage strong relationships with authorities and in-depth knowledge of Chinese regulatory processes and timelines to help you identify the best approach to keep your submissions on track, saving you critical time and money. 

PHDS provides services for our clients, including:

I. Clinical Development

1.

Clinical Trial Management (Local and Global multi-center study)

2.

Clinical Data Management

3.

Programming & Statistical Analysis

II. Regulatory Compliance

1.

IND and NDA (Imported Drug) /OTC

2.

IND and NDA (Domestic Drug) /OTC

3.

Medical Device Registration (Imported and Domestic Products )

4.

API & Pharmaceutical Excipient Registration (Imported and Domestic Products )

5.

Pharmaceutical Packaging Registration (Imported and Domestic Products )

6.

Functional Food Registration (Imported and Domestic Products )

7.

Novel Food Registration (Imported and Domestic Products )

8.

Food Additive Registration (Imported and Domestic Products )

9.

Cosmetics Registration (Imported and Domestic Products )

10.

Disinfectant Registration (Imported and Domestic Products )

11.

Drinking Water Device Hygiene Certificate Application

12.

Drug Registration Renewal (Re-registration) and Supplementary Application

13.

Imported Food Package Label Evaluation and Registration


III. Training

1.

CRA Training

2.

Clinical Data Management Training

3.

Biostatistics Training

4.

Medical Writing Training

 IV. Technical Services

1.

Policy/Regulation Consultation

2.

Market Access Service

3.

Process Development and Modification, Technical Parameters Investigation

4.

Specification Development and Modification


Request a proposal now