Organizer
Co-Organizers
Supporters
Arrangement
April 25-26,2019
Day one morning-Global Industry trends

Day one afternoon to Day two

Stream A-- Drug Substance

Stream B-- Formulation Design and development

Stream C-- Analytical Development and Support

Stream D-- Regulatory Planning Session

Stream E-- BE Studies Session

Related Event
DDF Asia 2013

Sponsors

Protech Pharmaservices Corporation (PPC)
 

Protech Pharmaservices Corporation (PPC)was founded in 1997 in Taipei, Taiwan to meet the growing demands for R&Doutsourcing from the Pharmaceutical and Biotech industries in the Asia-Pacificregion. Working with its worldwide customers as a leading regional ContractResearch Organization (CRO), PPC group provides professional services in“Clinical Research” (Phases I to IV) and “Contract Laboratories” (Central andBio-analytical Labs).

http://www.ppccro.com/

BioPharma Services,
 

BioPharma Services, Inc. is a well established and client-focused, Contract Research Organization specializing in Bioequivalence Studies, 505b2 program, and Phase I/IIa Clinical Trials, and Bioanalysis, serving pharmaceutical, medical device and biotechnology companies globally.  Our headquarters are located in Toronto, Ontario, Canada, with a 180-bed clinical facility including a 14-bed Phase I unit and a 120-bed clinical facility in US Columbia. Our state of the art Bioanalytical laboratory allows for the successful execution of the most complex of studies with timely and with high quality. Our strong scientific and professional experience allowed us to successfully conduct complicated BA/BE and Phase 1 trial as well as HAL studies. BioPharma has been inspected by US FDA, Health Canada, EMA (ANSM & DKMA), UK MHRA, and ANVISA.

IMPACT Scientific Instrument Co.,Ltd
 

IMPACT Scientific Instrument Co.,Ltd ( stock code: 830992) is a Hi-tech company that specializes in environmental detection and food security, provides R & D, production and sales in environmental monitoringinstrument, analysis instrument,related supplies and software.

Our major clients are environmental monitoring laboratories, pollution monitoring companies,universities, scientific research institutions, the third party testing organizations, large biology & food enterprises, etc.

Shandong BestcommPharmaceutical Co., Ltd.
 

Shandong BestcommPharmaceutical Co., Ltd. was established in August 2000, which is engaged in R&D ofnew pharmaceutical products. It is the first enterprise of its kind in China obtainedthe Certificate of Conformity of Quality Management System Certification (ISO9001:2008) and passed the Intellectual Property Management System certification(GB/T 29490-2013), it has won a number of honorary certificates such as the"National Technology Transfer Demonstration Institution", "FirstTop Ten Technology Transfer Institutions in Shandong Province". In March2016, it was officially listed on National Equities Exchange and Quotations(NEEQ) under the stock code 836534.

The company currently is staffed with more than 400 R&Demployees and equipped with more than 100 high-performance liquidchromatography systems. Over 330 new pharmaceutical products have beensuccessfully developed and over 210 products have been granted “New Drug Certificate”or “Drug Registration Approval”, additionally over 60 patents and trademarks havebeen granted. Now, it has established long-term stable cooperativerelationships with more than 200 pharmaceutical enterprises including more than40 of Top 100 enterprises of Chinese Pharmaceutical Industry and more than 50listed companies.

We will continue to be guided by the "Integrity,Innovation, Cooperation and Win-Win" principle to create more value forour customers, and carry out the noble mission of “Defense of people’s health” togetherwith outstanding enterprises.

DXC
 

ISI (China)Co., Ltd. is a wholly foreign company owned by DXC (DXC Technology).  We provide submissions solutions, processservices and professional software with professional technical support service.Our company was among the first professional services firms to deliverelectronic submissions to the industry and has since delivered hundreds of electronicCommon Technical Documents (eCTD) submissions. And the customers come from thepharmaceutical industry all over the world. Most global Top 50 pharmaceuticalcompanies are our customers, such as BMS, AbbVie, GSK, etc. Besides those customersfrom EU and US, we have developed some customers from China and Asia, andprovide our standard professional service to help them submit Application toFDA and EMA, such as the well-known companies Tasly, Hisun and Celltrion.Recently, with the fast development of pharmaceutical industry in China, wesupport many Chinese pharmaceutical companies for their globalization with ourcapabilities and experiences.

ISI (China)Co., Ltd. provide these types of products and service:

  • Publishing Tools: CTD templates and formattingtool, BM & HL tool, eCTD publishing and validation tool

  • Dossier Publishing Service: Publishing of paper,NeeS, and eCTD format dossier for different agency around the world.

  • Consulting Service: Regulatory Consulting,Processing Consulting and SOP review

  • Training Service: Training course of industrybackground, regulatory, software function, and submission publishing process,etc.

LGC
 

LGC is an  international life sciences measurement and testing company, building leading  positions in sustainably growing markets.

We provide reference  materials, genomics solutions and analytical testing products and services,  based on our innovations and own intellectual property. We work with  customers in the pharmaceuticals, agricultural biotechnology, food,  environment, security and sports sectors as well as with governments and  academia to achieve excellence in investigative, diagnostic and measurement  science. Our offering is underpinned by our heritage and expertise in  regulation, accreditation and standard setting. We help customers conform to  international statutory and regulatory standards.

Science is at the heart of all we do - for a saferworld!

博志研新
 

Shanghai Bocimed Pharmaceutical Co., Ltd., located in Shanghai Zhangjiang High-Tech Park, is a high-tech enterprise certificated by Shanghai government. In the R&D team with more than 100 members, 40% have Ph.D. or Master Degree. The R&D center of the company is more than 2500m2, and the investment for the facilities is above 20 million RMB. Bocimed is among the earliest which has got the ISO9001:2015 certification.

The company is engaged in the whole process of drug development including R&D of high-end generic drugs, quality consistency evaluation for generic drugs, clinical research and registration service, and provides pharmaceutical companies as well as the company itself with highly-competitive new drugs.

In the 10 years after the company was founded, Bocimed has established cooperation with about 100 local and foreign pharmaceutical companies and has got good reputation. Bocimed is also listed in Top 50 pharmaceutical R&D enterprises in China.

ViaClinical Ltd
 

ViaClinical Ltd is a clinical CRO specializing in bioequivalence studies and provides services to pharmaceutical companies and R&D institutions to conduct Assessment for Quality and Interchangeability between generic and brand drug products.  We havesuccessful experiences in the WHO program for Prequalification of Medicines, as well as CFDA submissions.  We work with GCP and GLP compliant clinical sites in China and India.

 

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Sponsors
  • Protech Pharmaservices Corporation (PPC)
  • BioPharma Services,
  • IMPACT Scientific Instrument Co.,Ltd
  • Shandong BestcommPharmaceutical Co., Ltd.
  • DXC
  • LGC
  • 博志研新
  • ViaClinical Ltd
Media Partner
  • yg
  • swwy
  • bio1000
  • phex
  • pharma china
  • Insight
  • dxy
  • bio-equip
  • GBI
  • PharmaVision
  • ipt
  • Bioon
  • Lingmed
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Luke Xia