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Mar182025

New Beginnings, New Horizons: A Strategic Merger for Enhanced Pharmaceutical Solutions

Hangzhou, February 12, 2025 – REACH24H BaiPharm (Ruiou Baiyao (Hangzhou) Pharmaceutical Technology Co., Ltd.) and Accestra Consulting Company (Hangzhou Jingchi Technology Co., Ltd.) are pleased to announce a landmark merger that will further strengthen the delivery of regulatory and compliance services across the pharmaceutical industry. Effective February 12, 2025, this strategic merger integrates Accestra’s technical expertise into BaiPharm’s global service framework, with all services…

Nov182024

China NMPA Issues New Regulations on Designating Domestic Agents for Overseas Drug MAH Compliance

News

November 14, 2024 The National Medical Products Administration (NMPA) has officially released the Interim Provisions on the Management of Domestic Agents Designated by Overseas Marketing Authorization Holders (MAH) of Drugs, with new regulations effective from July 1, 2025. These measures are set to strengthen the oversight of overseas MAHs by mandating the appointment of a…

Oct242023

DIA Global Forum for Qualified Persons for Pharmacovigilance (QPPV): Accestra to Present China RPPV/QPPV at DIA Global Forum 2023 in Amsterdam

Events, Offline Exhibition

This Forum provides valuable insights into the most pressing issues QPPVs are facing today. This event has limited capacity, register early! Time and Location: 8 – 9 November 2023 | Amsterdam, Netherlands Meet us in Amsterdam, engage with our speakers face to face about China QPPV requirements and practices, and get real-time feedback for…

Jul252023

CPHI Barcelona: Accestra to Present China Biologics Accelerated Registration at BioProduction of CPHI 2023

Events, Offline Exhibition

Time and Location: 24 – 26 October 2023 | Fira Barcelona Gran Via, Spain INTRODUCTION CPHI BioProduction is dedicated to leveraging partnership and collaborations to achieve greater success for production and market access of biologics. We are thrilled to be part of this exciting conference in the vibrant city of Barcelona on 24-26 October. We…

Jul212023

CPHI Barcelona: Accestra to Present China Pharmacovigilance at BioProduction of CPHI Europe 2023 in Barcelona

Events, Offline Exhibition

Time and Location: 24 – 26 October 2023 | Barcelona, Spain Meet us in Barcelona, engage with our speakers face to face about China GVP and relevant regulation changes, and get real-time feedback for your questions. INTRODUCTION Pharmacovigilance regulations in China are constantly evolving and rapidly changing. With China becoming increasingly important for pharmaceutical companies,…

Jun72023

Pharmacovigilance in China Webinar

Pharmaceutical, Webinar

Accestra Webinars In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 21 June 2023. Pharmacovigilance in China The webinar will cover these topics: Overview of China PV framework Updates on China’s GVP policies Updates on China’s GVP policies Best practices for compliance with China’s GVP requirements and…

Mar102023

TOPRA Webinar: Comparison Of China DMF With EU And US – Accestra Consulting

Events, Webinar

Click To Download/Read The Full Q&A Content Click To Download The Slides Q1: If have integral DDC product with lots of device (packaging) info in Modules 3.2.P.2.4 & P.7 can you simply x-ref to these sections for safety, tesing/CoA’s, stability etc. A1: Considering the definition of DDC product in China could be different with other…

Mar102023

TOPRA Webinar: Comparison Of China DMF With EU And US – Accestra Consulting

Events

Q1: If have integral DDC product with lots of device (packaging) info in Modules 3.2.P.2.4 & P.7 can you simply x-ref to these sections for safety, tesing/CoA’s, stability etc. A1: Considering the definition of DDC product in China could be different with other countries, it is crucial to clarify the classification of DDC products in…