Burleson Research Technologies

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.

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

TCG Lifesciences Pvt. Limited (formerly "Chembiotek Research International"​) is a leading global Contract Researchand Manufacturing Services (CRAMS) company in the area of drug discovery and development. We started our operations in 2001 in Kolkata, India and currently have our presence in the United States, Europe, and Japan.
We have a strong talent pool of 800+ qualified and trained scientists (including 150+ PhDs), drawn from the best domestic and international institutes and industry. Our services span chemistry, in vitro and in vivo pharmacology, analytical development and validation, and specialty chemicals. We offer specific/functional solutions to integrated projects across multiple therapeutic areas with specific focus on Inflammation & Pain, Infectious Diseases, Central Nervous System and Oncology. Our research infrastructure includes world-class chemistry and biology laboratories, animal facility, electrophysiology laboratory, BSL 2 laboratory, and cGMP facilities at our R&D centers.
Our Offerings:
DISCOVERY SERVICES
Functional Chemistry
• Scaffolds & Building Blocks
• Library Synthesis
• Parallel Synthesis
• Medicinal Chemistry Singletons
• Solid Phase and Solution Phase Peptide Synthesis
Functional Biology
• In vitro Pharmacology
• ADME
• Pharmacokinetics and Pharmacodynamics (PK/PD)
• In vitro Toxicology
• In vivo Pharmacology
Fully Integrated Services
• Medicinal Chemistry Design
• Lead Generation
• Lead Optimization
• Preclinical Candidate Selection

DEVELOPMENT SERVICES
• Rapid Scale-Up and cGMP Kilo Labs
• Route Evaluation
• Hazard Assessment & Reaction Calorimetry
• Process R&D
• Clinical Trial Materials Preparation
Analytical Services
• cGMP Analytical Lab
• Methods Development & Validation
• Forced Degradation Studies
• Impurity Profile Determination
• Impurity Isolation and Characterization
• Preparative Chromatography (chiral, SFC, and HPLC)
• Reference Standards Management
• ICH Stability Studies
MANUFACTURING SERVICES:

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

CSBio is a leading peptide and peptide synthesizer manufacturing company located on the edge of Silicon Valley in Menlo Park, California. Since 1993, CSBio has been providing high quality custom peptides, cGMP peptides and automated peptide synthesizers to the global biotech community. Our peptide products and peptide synthesis equipment can be found in peptide production laboratories and pharmaceutical companies worldwide.

CSBio now also offers solid phase peptide synthesis resins as well as high quality Fmoc and Boc protected amino acids for use in both R&D and cGMP peptide manufacturing. Our state of the art cGMP manufacturing facility provides cGMP peptides for preclinical and clinical programs and our commercialization and regulatory teams can take you from toxicology studies through market commercialization. Our product line also includes a complete list of generic peptide APIs including the most widely used peptide APIs in the industry. Whatever your peptide requirements, CSBio can assist you in reaching your ultimate goals by offering high quality products and world class support.