Biotecnologie BT S.r.l.

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

Barrow-Agee Laboratories was incorporated in 1917 in Memphis, Tennessee, by Edward Barrow and Worthen Agee as a privately held and independent testing laboratory. With emphasis on quality and fast service, our FDA registered laboratory provides comprehensive expertise in support of food safety and the analysis of foods, ingredients, feeds, animal fats and vegetable oils. Using current technology and official methodology to perform complete analytical chemistry and microbiological services, our trained scientists are prepared to support the individual requirements of a diverse client base. Barrow-Agee is ISO/IEC 17025:2005 accredited for microbiology, metals, pesticide residues and drug residues. We are also USDA accredited for Chlorinated Pesticide residues. We participate in proficiency testing programs sponsored by API, AOCS, USDA, CFIA, and AAFCO. Accurate analysis, along with our attention to personalized customer service, has enabled Barrow-Agee Laboratories to provide the very best analytical services to our clients for over 100 continuous years.

Mission Statement

To provide consistent, reliable and affordable analytical services to our customers by means of approved methodology, state of the art technology, efficient customer service and knowledgeable technical support.

Quality Statement

The Management team is committed to remain in compliance with applicable quality standards for food testing laboratories for both Microbiological and Chemical analysis, and to satisfy the requirements of our clients, regulatory authorities and organizations providing recognition.

Accutest, a global independent and internationally accredited Contract Research Organisation (“CRO”), with more than 20 years of experience and over 700+ employees in supporting the end-to-end services for global bio-pharmaceutical, biotech, medical device, nutraceutical and FMCG companies. Accutest is the market leader among independent CROs, with the highest quality standards and quick turnaround times. We have a strong regulatory track record and numerous accreditation/approvals from global regulatory agencies.

We offer services in 3 verticals:
1. Bio-availability and Bio-equivalence studies (BA/BE) -
2. Clinical Development Services (CDS)- Phase II - IV studies, Post marketing, Investigator initiated & stand alone services (medical writing, regulatory consultancy, clinical data management)
3. Biologics Services - Solutions for biosimilars, novel biologics and non-biological complex generics

Successfully cleared below inspections:
USFDA – 33 times (latest Nov, 2018)
WHO – 23 times (latest Jan, 2019)
DCGI- 20 times (latest Oct, 2016)
EMA – 8 times (latest Dec, 2017)

Anapharm Bioanalytics is a customer-focused bioanalytical CRO specialized in small and large molecule bioanalysis. Led by a team with over 30 years’ experience in method development, validation and sample analysis, we support drug development programs for the pharmaceutical, biotechnological and generic industries worldwide.

Equipped with state-of-the-art LC-MS/MS and LBA technology platforms, Anapharm Bioanalytics provides an array of services including PK studies, biomarker testing and immunogenicity assays throughout preclinical and clinical stages. Our global network of partners allows us to provide full-service outsourcing solutions to conduct preclinical, Phase I-IV clinical trials, and bioequivalence studies for international registration.

Our clients benefit from a deep scientific expertise combined with a robust quality system. All our activities are compliant with GLP and GCP, having undergone 20 regulatory inspections by the FDA, several EU Health Authorities and ANVISA (Brazil).

Whether your drug candidate is a new chemical entity, a new biologic, a generic or a biosimilar, do not hesitate to contact us at info@anapharmbioanalytics.com.

This channel is intended only for US and Canadian visitors. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada. An unaffiliated and unrelated company, Merck & Co. holds the rights in the trademark MERCK in the US and Canada.

Bringing pharma and biopharma healthcare solutions to life is complex, requiring specialist knowledge and expertise at every step.

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