Regulatory Intelligence

The Chinese regulatory system is distinctive, and therefore challenging to navigate. China has its own regulatory agency and rules of conducting product registration. Thus, having sufficient knowledge and experience with every regulatory body and its own set of rules is the key of success.

ACCESTRA can provide the most effective and efficient strategy for your product registration with a fair price. We have a pharmaceutical background and a team of experts with many years of experience in international and Chinese regulatory affairs. We specialize in highly complex and difficult regulatory projects of overseas pharmaceutical companies. With our comprehensive interpretation of regulations and customized registration strategy you are able to make the right decision at every step in the process and ultimately obtain the market approval.

Please contact us for more intelligent solutions in the following areas:

• Interpretation and Analysis of Regulations
• Product Assessment and Classification
• Customized Registration Strategy

In 2015 China underwent significant regulatory reforms of drug administration system and officially became a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The new system is aligned with administration rules of the European Medicines Agency (EMA) and the U.S. Food and Drug administration (FDA), which makes an international approach of drug registration in China. For your understanding, we provide customized training in every aspect of pharmaceutical regulatory affairs in China. You can learn the new rules and legal requirements comprehensively and efficiently in our half-day to multiple-days training sessions. According to your needs, we can provide regulation interpretations, Q&As written by our regulatory experts as well as warnings of regulation updates in forms of monthly reports and newsletters.

Please contact us for more information about the following service:

• Customized Training

I.Regulatory affairs Guidance and Pathways to China

II.Product Registration (NDAs, ANDAs & MA + MAH)

III.Drug Master File (DMF) Filing

IV. GMP Compliance and Certification

V.Validation of Manufacture Process, Methods & System

• Customized Intelligence Service

I.General/Specified Regulation Interpretation

II.Warnings of Regulation Updates (Monthly Report, Newsletter)

• Local Experts Consulting

I.Technology Transfer

II.Techniques of Crystal Study