BioAnalytix

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.

This is why MilliporeSigma offers the BioReliance® portfolio – an offering of exceptional, risk-mitigating approaches, testing, critical services and customized, complete solutions to help you bring life-changing drugs to market, faster. We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. With locations worldwide, we offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. For more information, visit www.bioreliance.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.

This is why MilliporeSigma offers the BioReliance® portfolio – an offering of exceptional, risk-mitigating approaches, testing, critical services and customized, complete solutions to help you bring life-changing drugs to market, faster. We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. With locations worldwide, we offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. For more information, visit www.bioreliance.com.

Clinlogix is a Global Clinical Research Service & Consulting Organization working to improve human quality of life by supporting innovation in the life science industry. Its full suite of clinical research services supports the regulatory and clinical development pathway of medical devices, pharmaceuticals, biologics and diagnostics from proof of concept/discovery, early feasibility/first-in-human, through pivotal and the post-marketing/safety surveillance of client products. The company delivers this global expertise by way of its regional office locations in the US - Spring House, Pennsylvania, Europe - Mainz, Germany, Latin America - Medellin, Colombia and Asia Pacific - Tokyo, Japan.