Organizer
Co-Organizers
Supporters
Arrangement
April 19-20,2018
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 and 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/

Proswell Medical Company
 

Proswell Medical Company, established in 2004, provides a wide range of world-class services for clinical trial and pharmaceutical development for domestic and oversea customers. Proswell takes on the responsibility for creating an international brand by local clinical Contracted Reasearch Organization (CRO) and promoting the development of China CRO Industry. Proswell successfully passed ISO 9001:2008 Quality Management System Certification in January 2010 and became the first local certified CRO in China. This achievement represents Proswell’s sincerity, dedication, professionality and commitment to its partners and customers to provide clinical trial service with supreme-quality and balanced-efficiency!

http://www.proswell.com.cn/


Beijing LEVA Pharmaceutical Co. Ltd
 

Beijing LEVA Pharmaceutical Co. Ltd (hereinafter referred to as LEVA Pharmaceutical) is the first CRO company in China that performs Phase 0 drug clinical trials. Founded in 2014, LEVA Pharmaceutical provides one-stop clinical research services, including phase 0 ~ phase IV clinical trials, registration, data management and statistical analysis, bioequivalence test, and GCP audit. As a professional contract research organization engaged in clinical studies and pharmaceutical medicine statistics, Our service covers more than 10 sectors, including oncology, cardiology, respiratory, gastroenterology, pediatrics, neurology, urology, anti-infection, gynecology, endocrinology, rheumatology, stomatology, otolaryngology, and dermatology, LEVA Pharmaceutical endeavors to help you achieve your goal with customized solutions.


Nikyang Enterprise Limited
 

Nikyang Enterprise Limited is the sole partner inAsia for a selected group of world-renowned European manufacturers of advancedlaboratory equipment.  As the region’sleading supplier of innovative laboratory automation solutions, Nikyang ishelping to transform QC and R&D labs in China and beyond from inefficientmanual processing to fully-automated high-throughput operation.  Nikyang adds value for customers across awide range of sectors from pharmaceuticals, petrochemicals, paint &coatings, food to government labs and university research centres.  Its flexible integrated and upgradablemodular robotic platforms are backed up by comprehensive consultancy, serviceand support through the company’s extensive sales network.

For more automated solutions in pharmaceuticalarea, please visit www.nikyang.com, or come to our Booth (No. 22).


Mettler-Toledo
 

Mettler-Toledo Automated Chemistry Department, also known as AutoChem with headquarters located in Columbia, Maryland, focuses on automated reactor, reaction calorimeter and on-line analytical technology for R&D labs, providing professional solutions to crystallization, reaction analysis, safety assessment and process optimization. AutoChem maintains a strategic cooperative relationship with multinational pharmaceutical and chemical companies, such as Merck, Pfizer and BMS, and continuously help our customers with the innovation from molecular discovery to industrial production.


Clarivate Analytics
 

Who we are

Clarivate Analytics accelerates the pace of innovation by providing trusted insights and analytics to customers around the world, enabling them to discover, protect and commercialize new ideas faster. We own and operate a collection of leading subscription-based services focused on scientific and academic research, patent analytics and regulatory standards, pharmaceutical and biotech intelligence, trademark protection, domain brand protection and intellectual property management. Clarivate Analytics is now an independent company with over 4,000 employees, operating in more than 100 countries and owns well-known brands that include Web of Science, Cortellis, Derwent,CompuMark, MarkMonitor and Techstreet, among others.

https://clarivate.com/about-us/what-we-do/

EAG
 

EAGis a world leader in pharmaceutical testing and support. OurMaterials Sciences division focuses on non-GMP, investigative research. We havean unparalleled collection of chromatographic, spectroscopic and imaginginstruments that help us solve the most complex of problems. We can design fullreverse engineering programs to investigate how pharmaceutical products(including topicals, tablets, capsules, etc.) are put together and what exactingredients were used. Our generic pharmaceutical customers can then use thisinformation for the preparation of their own equivalent products and use ourdata to support their ANDA filings (or equivalent for other jurisdictions). Wework with customers all over the world including Asia, Europe, Australia andNew Zealand. We also perform material characterization (API polymorph, etc.) aswell as contaminant and impurity identification work to support product qualityprograms.

OurLife Sciences division brings decades of experience and expertise to thedevelopment and commercialization of small molecule drugs, biopharmaceuticals,antibody-drug conjugates (ADCs), drug-device combination products and othertherapies. From designing IND-enabling studies to delivering full CMCanalytical and QC support, we join your R&D team as a true partner. EAGscientists take time to understand both your commercial goals and the uniquecharacteristics of your compound. We provide expert guidance to balanceregulatory expectations with expediency and cost, and approach technical challengeswith flexibility and resolve.


Bruker (Beijing) Scientific Technology Co.,Ltd
 

Bruker Optics is a part of the Bruker Corporation and offers FTIR, FT-NIR, Raman, TeraHertz spectrometers and imaging spectrographs for various markets and applications. Bruker Optics R&D and manufacturing centers are in Ettlingen, Ger­many, with supporting technical centers and offices throughout Europe, North and South America and Asia.

Whether it’s a high-end research system, a life sciences tool, a routine quality control instrument or a process analyzer, Bruker Optics offers a wide variety of innovative analytical tools for all your demanding needs. The countless innovations found on our products, delivering unmatched analytical power, represent our philosophy of think forward.

http://www.bruker.com

Green Griffith
 

Green Griffith focuses exclusively on IP issues involving pharmaceuticals, chemistry and biotechnology—specializing in litigation.  Our attorneys share decades of litigation experience assisting both brand and generic companies navigate the Hatch-Waxman Act.  As stated in AIM Patent 1000: “Green, Griffith is a uniquely talented and experienced intellectual property firm that has been making serious waves in the biopharmaceutical market.  As for the Green, Griffith modus operandi, they are tirelessly committed to helping their clients succeed; collaborating with their clients as strategic partners – albeit partners who happen to be excellent at litigation.”

Acknowledged leaders in our field, we partner with our clients to provide strategic formulation, portfolio and litigation counseling concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2) and ANDA applications.  Pre-litigation, we provide strategies and opinions directed toward attaining each client’s goals, whether this involves API and excipient selection, trade dress, formulation attributes, labeling or portfolio development.  Our trial attorneys—who have hard science backgrounds in chemistry, biology and/or biotechnology—then work with each client to execute the desired strategy—whether this involves litigation in the federal courts or IPR practice before the PTAB.  Visit: www.greengriffith.com


Beijing Scinovo Laboratories Ltd
 

In November 2016, Beijing Scinovo Laboratories Ltd was established, The registered capital was RMB20 million, the actual investment is nearly RMB 40 million. The newly establishedlab is more than 1100 m2, and the design and construction areadopted the International Standards .Our lab uses AB mass spectrometers(API4000, 4500, 5500) recommended by FDA as primary equipment for testing. Wealso use Watson LIMS software, which is the most popular internationallaboratory management system.

Beijing ScinovoLaboratories Ltd focuses on biological samples analysis, including the consistencyevaluation of generic drug/study of bioequivalence/Phase I clinical trial ofinnovative drug. We have established a strategic partnership witha large number of domestic pharmaceutical companies and clinical researchinstitutions.

We are strivingto establish an open testing platform , which is not only satisfiedwith domestic and international standards, but also provides Laboratory R& D and production services for global pharmaceutical, biotech andmedical devices fields from drug discovery to marketization process.


kc
 

Qingdao Science Innovation Quality Testing Co., Ltd is an one-stop third-party analysis, research and development service with certifications of CMA and CNAS. It always devotes itself to providing high-level services about compatibility test of medicine packaging material, preparation quality control, analytical methodology validation, health food analysis, quality control of traditional Chinese medicine.

http://www.kcscin.com


hengxing
 

EverPro Medical Co., Ltd. is located in High-Tech Park in Changsha, China, and provides a range of services including analysis of biological samples from drug clinical and pre-clinical trials, clinical laboratory tests and biomarker researches, as well as process and statistical analysis of PK data. EverPro owns a 1800-m2 lab equipped with several advanced LC-MS/MS systems, a sophisticated temperature/humidity monitoring system, a well designed data storage and backup system and so on. EverPro has established a high-level quality management system with OECD/CNAS GLP and ISO 17025 standards, and meeting relavant regulatory requirements. The company has built up a team of around 30 persons, over 50% of which have MS and PhD degrees.

http://www.everpro-medical.com/

CTSmed
 

Beijing CTSmed Co.,Ltd., is the development of comprehensive professional clinicalresearch outsourcing company dedicated to the Internet platform of innovativethinking. The company was founded in November 30, 2010, and is listed in the newover-the-counter market(number 831257) in October 2014. Companies adhering tothe "integrity" and "efficient" and "excellence"and "innovation" concept, pay close attention to customer needs,solvethe shortcomings of information opaque, non sharing, and non interoperabilityin the implementation of clinical research,strict implementation of the projectoperation, the multi quality control of clinical research. Through the closecombination of the Internet, it is possible to "make clinical trialssimpler and make health simpler". We will strive to build systematicservices for clinical trial and whole industry chain. We are committed toproviding systematic and high-quality clinical research services for domesticand foreign pharmaceutical enterprises, and aspire to become one of the mostinfluential companies in clinical research.

http://www.ctsmed.com


NeoTrident
 

NeoTrident is a leading provider of scientific innovation lifecycle management software, and supports both the life science and materials science industries and organizations.

As an industry-leading information technology company, NeoTrident portfolio is focused on integrating the diversity of science, experimental processes, and information requirements across research, development, QA/QC, and manufacturing. Capabilities cover scientific data management; biological, chemical, and materials modeling and simulation; open collaborative discovery; scientific pipelining; enterprise laboratory management; enterprise quality management; operations intelligence and business intelligence. We have a proven track record of enhancing customer’s management efficiency, decision making, and innovation capabilities through our integrated solutions. And we are willing to provide the best practice informatic solutions and services for enterprises and research institutions in China. 

E-Zheng
 

Shenzhen E-Zheng Technology Co., Ltd is a high-tech enterprise integrating technologydevelopment, equipment sales and after-sales service. E-Zheng Technology is mainly to provide customers with continuous flowprocess solution and laboratory system solution. E-Zheng Technology is a professional distributor and technical serviceprovider for continuous synthesis equipment and analytical instruments withcomplete and professional technology and personnel configuration.

In China, E-Zheng Technology is exclusive distributorand technical services provider for Chemtrix B.V. company (Micro Reactor),  AM Technology (continuous stirring multistagereactor, catalytic hydrogenation system), the NiTech company (continuouscrystallization, continuous synthesizer) and AWL (continuous filtration anddrying apparatus). E-Zheng Technology can provid continuous synthesis,extraction, online continuous crystallization, online filtrationdrying, online analysis forming a acomplete continuous process solution. E-Zheng Technology established joint laboratory for micro reactorcontinuous flow technology with Zhejiang University of Technology (College ofPharmacy), Hebei University of Technology (colleage of chemical engineering)and Fudan University (chemistry department). Joint Laboratories are committed to promoting the continuous flow process inorganic synthesis, fine chemical, pharmaceutical, energy and material food andbeverage industry. JointLaboratories can also provide services to develop new flow process and help customerschange the traditional batch process into flow process promoting the pharmaceutical and fine chemicalindustries turning from traditional batch process into green, safe, fast,economic continuous flow process.

http://www.e-zheng.com

Sundia MediTech
 

Founded in 2004, Sundia MediTech CompanyLtd. is a leading China-based CRO providing a broad range of high-quality, costeffective drug discovery and development services.  Capitalizing on its broad service offerings,experienced scientists and advanced research facilities and equipment, Sundiahelps its customers discover and develop novel drug candidates efficiently.  Sundia currently provides services to over160 customers globally, including a vast majority of the top 20 pharmaceuticaland biotechnology companies in the world, as well as fast-growing biotechnologyand specialty pharmaceutical companies and renowned academic and researchinstitutions.  Sundia currently boasts anexperienced and strong R&D tem, comprised of over 700 employees, of over70% have post-graduate degrees and an average of 15 years of relevant industryexperience.  The Company conducts itslaboratory and development activities in three primary facilities in China: a)Shanghai Zhangjiang Hi-Tech Park; b) Shijiazhuang; and c) Taicang.


Tegent
 

About Tegent

Since 1992, Tegent has been a respectful leader in equipment distribution.

We are passionate believers that technology brings values of a quality life to our customers, to our markets and to our society and to the world.

We provide and support quality scientific instrument, industrial testing and process equipment to different kinds of customers including universities, research institutes, government organizations, inspection authorities, and industrial companies such as pharmaceutical, petrochemical, food & beverage, electronic and etc.

We have professional and energetic teams to manage products and to offer quality service, bring technology and application to the markets and serve our customers.

We commit to advocate healthy and happiness, sincerity and integrity, openness and honesty and develop each of our team to have the most possible him/her in our organization.

We believe we are making a better difference to our world.

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.

 

ACDLABS
 

Our main objective is to enhance an organization’s ability to effectively fast-track chemistry projects by fine-tuning scientist productivity through smart decisions based on analytical chemistry and the potential biological endpoints of their products.

With over two decades of experience boosting the productivity of synthetic and analytical chemistry laboratories worldwide, our software's ability to understand and preserve the relationship between chemistry projects and analytical data is unmatched. As scientific expertise evolves and projects move forward, we help keep analytical data alive and relevant by unlocking the untapped value hidden within chemistry projects, decisions, and the data that drives them. We ensure that the context and knowledge extracted from projects is retained and leveraged to quickly resolve challenging problems and foster collaborations between groups and departments. All of this is achieved in a fully integrated way that preserves and enhances the performance of existing and future informatics systems.

 

DKSH
 

DKSH provides market entries into Asia, Europe and the Americas through a wide range of partnerships for: Medium-sized enterprises with innovative, high-quality products. DKSH China is an international trading and marketing group with it’s headquarter in Zurich, Switzerland. Since 1990, DKSH has established trade, co-operation and friendship with China. Our products have been widely using in petroleum, petrochemical, pharmaceutical, powder, food industries etc. inChina.

With its many sales representative offices and service centers in all over the China, DKSH provides professional analytical instruments, includes:

  • Particle Size Analyzer Instrument /photo optical particle analyzer-MICROTRAC

  • Autopol® Polarimeter, Density meter, Refractometer, Saccharimeters -RUDOLPH Research Analytical

  • HPTLC Densitometer -Biostep

  • Water Activity (a.w.) -novasina

Hotline: 4008 210 778

Http://www.dksh-instrument.cn

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)
  • Proswell Medical Company
  • Beijing LEVA Pharmaceutical Co. Ltd
  • Nikyang Enterprise Limited
  • Mettler-Toledo
  • Clarivate Analytics
  • EAG
  • Bruker (Beijing) Scientific Technology Co.,Ltd
  • Green Griffith
  • Beijing Scinovo Laboratories Ltd
  • kc
  • hengxing
  • CTSmed
  • NeoTrident
  • E-Zheng
  • Sundia MediTech
  • Tegent
  • 博志研新
  • ACDLABS
  • DKSH
  • ViaClinical Ltd
Media Partner
  • yg
  • swwy
  • bio1000
  • phex
  • pharma china
  • Insight
  • dxy
  • bio-equip
  • GBI
  • PharmaVision
  • ipt
  • Bioon
  • Lingmed
Contact Us

Luke Xia