ChemPartner

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging

Eurofins Advinus is your trusted partner for specialized discovery, preclinical and early clinical services. Our facility has 30 years of GLP experience in conducting regulatory studies in compliance with global regulations for supporting clinical trials and registration of substances and products globally.

We have over a decade of drug discovery experience for novel, first-in-class targets as well as fast follow on targets and have produced multiple assets that are in preclinical and clinical development. Our discovery services include comprehensive offerings from Medicinal Chemistry, to in vitro Biology, ADMET and Pharmacology.

We offer end-to-end services for a complete IND/IMPD package that includes Safety Assessment/Toxicology and Drug Metabolism and Pharmacokinetic (DMPK) studies along with Chemistry, Manufacturing and Controls (CMC) services.

DMPK services include full spectrum of in vitro screening services, assay development and validation with customized assays and PK studies. We also provide bioanalytical assay development and validation services in accordance with USFDA and EMA guidelines for both Novel Chemical Entities (NCEs), as well as Novel Biological Entities (NBEs) and Biosimilars.

We have successfully submitted enabled 80+ IND packages for submission to regulatory agencies across the world – including USFDA, MHA and EMA. We offer full range of toxicology services to support NDA filing. We have completed 65+ carcinogenicity studies.

BIONEEDS INDIA PRIVATE LIMITED is a Bangalore based Contract Research Organization providing Integrated Discovery, Development and Regulatory Services to Pharmaceutical,
Biopharmaceutical, Agrochemical, Industrial chemical, Herbal/Nutraceutical and Medical device companies.

Accreditation/Certifications
• National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forests and Climate Change, GOI.
• State Drug Controller as a Government approved Drug Testing Laboratory for carrying out tests on Drugs / Cosmetics and
• Raw Materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
• Review Committee on Genetic Manipulation (RCGM), department of biotechnology, GOI to conduct experiments on animals for DNA or Genetically modied resources
• Bioneeds is AAALAC certified for laboratory animal care
• Bioneeds’ in-house R & D unit is recognised by Department of Scientic and Industrial Research (DSIR)
• ISO 17025 certified for Biological evaluation of Medical Devices
• Bioneeds has best-in-class infrastructure equipped with state-of-the-art facilities with 2,50,000 sqft built-up area.
• Vivarium with 85 exclusive animal rooms built as per international standards
• Cutting edge Drug Discovery and Development Labs to support Medicinal chemistry, Biology, In vivo Pharmacology,
• Toxicology, Custom synthesis, Process R&D, cGMP manufacturing, Formulation and Analytical development services

MedChem Partners is a medicinal chemistry CRO founded in 2006 by Tsvetelina Lazarova and Steven Riesinger. The company is focused on using the extensive experience in early stage company formation and drug discovery to effectively advance small molecule candidates for clients by working closely with the client’s biology and/or chemistry resources. Our experts have extensive experience in moving projects from inception through discovery and into development up to IND enabling toxicology.

At MedChem Partners, we are experts at using synthetic and medicinal chemistry to develop small molecule therapeutics. Unlike large one-stop shops that spread their attention over a variety of tasks, we focus on what we know best. Our expertise is in formulating and implementing a plan to find and optimize small molecules which interact with novel or known biological targets. Whether you already have potential molecules in mind, or have just discovered a novel target, we can develop a plan to find and optimize compounds with therapeutic potential. Since drug discovery is a multidisciplinary endeavor, we have foraged close contacts with a variety of other service providers to augment our expertise in certain areas. Since each company is focused on what it does best, this approach allows us to tap into the best talent in each area. Through out network we have access to in vitro and in vivo testing, in vitro and in vivo pharmacokinetics, computer modeling and in silico prediction, formulation, scale-up and manufacturing, toxicology and regulatory filing, x-ray crystallography, intellectual property and patenting, and consultants in clinical, regulatory, manufacturing, pharmacology, and toxicology.

Your Partner for Toxicity and Immunotoxicity Studies

vivo Science is a Contract Research Organization located in Germany performing standard rodent toxicology and is specialized in immunogenetic and immunotoxicology studies. All studies are either Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) compliant depending upon the specific requirement.

Our experience is with the biopharmaceutical industry and large molecules as well as with small molecules. The study and report design are appropriate for submission to the pharmaceutical regulatory agencies. We also have experience in studies as described in the new European REACH guidelines for submission to the appropriate authorities.