Medical Policy Research


Medical/Pharmaceutical Consulting Services

 

As China's medical industry develops rapidly, CFDA and other China’s medical regulatory agencies have made frequent policy adjustments, making it difficult for enterprises in the industry to interpret the policies and regulations, resolve academic questions, and to collect and analyze market information, etc. Overseas medical organizations who want to enter into Chinese market lack understanding of China’s medical environment, and are pressing for the basis for decision-making in project approval, investment and other aspects. Giant Med-pharma Services can efficiently solve the problems above.

 

Giant has 17 years’ experience in the medical industry. Its service scale, resource perimeter, and industry experience are in a leading position in China. Giant has accumulated a wealth of information resources in the healthcare industry and has constructed a smooth communication pathway with the makers of industry standards and regulations, as well as with academic authorities (more than 2600 experts in different therapeutic areas). Giant has also participated in a number of national major special programs for drug and medical device R&D, helped hundreds of pharmaceutical companies, medical device companies, influential investigators in solving problems related to regulations, academic questions, market research, etc.

 

Types of Services:

Consulting on the Medical/pharmaceutical Regulations and Policies

- Registration of Pharmaceutical Products (including excipients/packing materials)

- Registration of medical devices

- Registration of health food and cosmetics

- Registration of hospitals and clinics

 

Counseling on Academic Medical Research

- Design and compilation of clinical study protocols

- Clinical study reports

- Medical intelligence analyses

 

Consulting on Healthcare Market

- Collection and analysis of competitive intelligence

- Investment Feasibility Study

- Consulting on domestic investment opportunities for imported products

- Market Research

- Industrial policy study

 

Classic Cases:

Consulting on Medical/Pharmaceutical Regulations and Policies

Case 1-  We work for a top 10 pharmaceutical global company in a long term project for more than 15 years on the interpretation of Medical/Pharmaceutical Regulations and Policies from

CFDA, MOH, we help dinated industry experts and resources to provide data support and academic argument which offered convincing scientific evidence for the argument report of the company. Finally, CFDA conditionally accepted the two-application and two-approval process for the registration of imported drugs. Therefore, GiantMed has become a long-term consulting partner of the company.

 

Case 2- CFDA will conduct on-site inspection of all products registered in China. Giant has assisted client preparing the SMF, writing the basic information for on-site inspection, help clients to communicate with CFDI (Center for Food and Drug Inspection of CFDA), including arrange the inspection time schedule. Due to the differences between China GMP and EU /FDA GMP, Giant can invited experts on China GMP to conduct CFDA GMP training, consulting and instruction for our clients, and help our clients to successfully pass on-site inspection of CFDA, and close the deficiency. Projects involved: Bruschettini S.R.L (Italy), Atlantic Laboratories Corporation (Thailand), Tai Tong Ah Co. (Pte) Ltd. (Singapore), etc.

 

Case 3-  we worked for EUSME for consultation, and through German Chamber of Commerce Giant introduced China registration regulations and China pharmaceutical market to Europe by integrating expert resources and collecting professional data and carrying out macro analyses of the significant industrial policies of China. The article was published in a German business journal, The German Chamber Ticker, in Aug 2017.

 

Case 4- Giant worked for clients to settle the dispute with CROs and distributors. Ensure the products can be distributed on China market, and the IDL renewed. Giant provides consulting schemes that aim to achieve maximized profit based on previous experience and reasonable interpretation of regulations. 

 

Counseling on Academic Medical/Pharmaceutical Research

Case 1-  A pharmaceutical company intended to develop a new ear drop product in China. Giant contacted the otolaryngologists and pharmacokinetics experts in Tongren Hospital, and experts in the evaluation expert base – to provide design consultation for the clinical trial, we designed the protocol do the clinical development management for the client.

 

Case 2-  The Phase I clinical trial of a Shanxi Pharmaceutical company failed to get the expected result, Giant team had a detailed discussion and contacted the most famous Phase I experts in PUMC Hospital and Tiantan Hospital, and they finally spot its design defect. Giant also held a consultation on trial protocol design for this company, redesigned the Phase I study, which successfully passed the evaluation of CDE.

 

Counseling on Medicine Market Analysis

The China CFDA regulations and healthcare market are different from western countries. All the enterprises need to conduct competitive analyses, market research and pricing for the target products. Giant has built the bridge of effective communication between commercial organizations and academic institutions/academics in market analysis fields, and has formed a set of systematic approach to provide the decision-making reference for enterprises in various aspects, including regulatory policies from CFDA and healthcare policies from MOH. Giant has offered relevant counseling services for dozens of enterprises up till now.

 

Case 1-  A medium-sized Austria pharmaceutical company with more than 30 ophthalmology products intended to know the ophthalmology market to make their market strategy in China. Giant thus provided the market research for the related products and the client was satisfied with the consulting results.

 

Case 2-  NRI(Nomura Research Institute)worked for a Japanese pharmaceutical company in purchasing a China pharmaceutical company. Giant provided consulting services on China CFDA regulations for NRI and helped with the evaluation of product pipeline.

 

Case 3- The Monitor Group, an American consulting company, worked for one of its clients to investigate the present state of China’s oral health industry. Giant conducted market and regulatory research for the company, including the interpretation of the regulations of dental care products registration, the market insight, and the study of the establishment and acquisition of dental clinics, etc.