Submit cDMF in China for your APIs, Excipients or packaging materials.
Submit an abbreviated new drug application (ANDA) for your generic drug approval by CDE
Arrange Pre-IND Consultation with CDE and obtain authorization to kick-start clinical trails in China.
Accestra Consulting is a specialist China regulatory affairs outsourcing partner for the pharmaceutical, medical devices and food industry. We deliver regulatory solutions in compliance with China NMPA (Formerly CFDA) regulations.
We believe in going the “extra mile” to help deliver quality work to our clients and support with finding the best regulatory pathway options to commercialisation.
We help our clients stay on the path to early approval of pharmaceutical products in China.
We provide end to end food regulatory compliance & market access requirements advisory.
We provide regulatory compliance advisory for finished cosmetic products, including registration & safety assessment.
We provide global feed and feed additive companies with registration advisory for China and Asian market.
Time and Location: 07 – 09 May 2024 |Pennsylvania Convention Center, Philadelphia INTRODUCTION CPHI creates connections and inspires partnerships across the global pharma community. Access endless opportunity to grow your business and expand your network at the heart of Pharma! We’re thrilled to announce that our Senior Regulatory Affairs Raymond Ng will take the stage…
Time and Location: 6-8 May 2024 |Berlin Congress Center Alexanderstraße 11, 10178 Berlin, Germany INTRODUCTION RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science,…
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…
Join free webinar on China Drug Master File (DMF) Filing for APIs, Excipients & Packaging Materials on Thursday 15th April, 2021, at 10:30 CEST time. The webinar will provide an overview of the requirements, regulatory pathways, how to register your DMF in China and a comparison between US FDA and EMA DMF systems and much more! Accestra and ELC group who are co-hosting, look forward to your participation.
Accestra’s Raymond Ng will be participating in Feed Additives Asia 2019 in Thailand Bangkok. Get in touch with Raymond Ng to hear about how Accestra Consulting works with global feed additive companies to support China regulatory requirements.
Date: Tuesday, 9th March, 2021 Time: 7:30 AM – 8:30 AM CST (China Standard Time) Price: Free of charge Click here to register. You will then receive an invitation to this webinar. Please note that the number of participants is limited.
Brought to you by New Zealand Trade and Enterprise (NZTE), this webinar series has been designed to help your business navigate the shifting digital landscape in post-COVID China.
Due to the US-China trade war, American delegates at Shanghai’s SIAL Food Expo decreased by 50% this year. No wonder China’s market has become more difficult for US firms when, for example, US wine tariffs are 70% (no FTA and trade war tariffs) while Australia’s are 0% (ChAFTA).
Brought to you by New Zealand Trade and Enterprise (NZTE), this webinar series has been designed to help your business navigate the shifting digital landscape in post-COVID China.
