ANDA, NDA, BLA Registration and Registration Renewal in China

ANDA: abbreviated new drug application; NDA: new drug application; BLA: biologics license application Legal Basis of ANDA, NDA, BLA Registration and R…

Pharmaceutical Service
Nov. 28th, 2022

Pharmacovigilance: how to comply with China’s Good Pharmacovigilance Practices (GVP)?

Pharmacovigilance is an important obligation for life sciences companies. Pharmacovigilance (PV), also known as drug safety, should be monitored throu…

Pharmaceutical Service
Nov. 21st, 2022

Market Access Strategy: why is it important for pharmaceutical companies and how to improve it?

Market access strategy is significant to win in the target market. A good market access strategy enables pharmaceutical companies to provide safe and …

Pharmaceutical Service
Nov. 17th, 2022

DMF Filling for Active Pharmaceutical Ingredients, Excipients and Packaging Materials

DMF: Drug Master File; API: Active Pharmaceutical Ingredient Legal Basis Drug Administration Law of the People’s Republic of China (2019 Revision); Pr…

Pharmaceutical Service
Nov. 16th, 2022

Clinical Trial Application, Bioequivalence Study, and Multi-Regional Clinical Trials in China

CTA: clinical trial application; BE study: bioequivalence study; MRCTS: multi-regional clinical trials Legal Basis Drug Administration Law of the Peop…

Pharmaceutical Service
Nov. 16th, 2022

Cross-Border E-Commerce for OTC Drug

E-commerce market in China has become one of the most developed ones in the world, accordingly, the competition is fierce. Well-functioning ecosystem …

Pharmaceutical Service
Oct. 31st, 2022

Local Agency Support for Pharmaceutical Companies

With its registered company in China, BaiPharm can be your trusted local authorized agent and provide support throughout the entire lifecycle of your …

Pharmaceutical Service
Jan. 05th, 2021

Customized Training for Pharmaceutical Companies

To help companies evaluate their strategies for pharmaceutical regulatory management from the complex regulations and policies, clinical research, GMP…

Pharmaceutical Service
Jan. 05th, 2021

Pharmaceutical & Medical Translation

To avoid delays in the review of product registration and to minimize the risk of rejection, it is critical for Chinese government officials to unders…

Pharmaceutical Service
Jan. 05th, 2021

Registration Strategy

BaiPharm relies on its years in the pharmaceutical field and a reliable team of professionals experienced in international and Chinese regulatory affa…

Pharmaceutical Service
Jan. 05th, 2021
15th Chemical Regulatory Annual Conference: Together We Break Barriers - CRAC2023
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