Compliance Services International

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.

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.

Oroxcell is an independent research organization (CRO) offering research services assessing the safety, toxicity and efficacy of active ingredients and finished formulations.

Specialized in in-vitro testing, particularly in 3D Human Models, Oroxcell is developing its business on two fronts:

• Safety & efficacy testing: From screening to GLP Compliant studies, we provide well established In-vitro platform, 2D and 3D models, for performing routine and regulatory safety testing, ADME (Absorption, Distribution, Metabolism, and Elimination) and Toxicity (sensitization, phototoxicity and genotoxicity) tests, bioanalytical studies, for evaluating pharmaceuticals, medical devices, cosmetics, nutraceuticals, home care and chemical products.

• Research & Innovation: Oroxcell provides a wide range of services including R&D project management and technical support, international consortium setup and management and regulatory & toxicology consulting.
We assist you in selecting or developing the best alternative testing methods for your safety and efficacy issues.

Oroxcell has been certified GLP compliant (Grade A, the highest grade) since 2011 by the French National Medicines and Cosmetics Safety Agency, ANSM.


Website: http://www.oroxcell.com
Contact: contact@oroxcell.com

Pacific BioLabs is the leading West Coast provider of GMP/GLP laboratory testing services supporting Medical Device, Pharmaceutical, and Biotechnology industries. As a CRO, we offer toxicology, biocompatibility, microbiology, sterility assurance, and analytical chemistry testing and research support services.

Pacific BioLabs’ mission is to contribute to the development of safe and efficacious medical products while maintaining rigorous scientific integrity and the highest standards of regulatory quality. We have a strong commitment to confidentiality, impartiality, and continuous quality improvement.

As The Service Leader in Life Science Testing, Pacific BioLabs continuously strives to meet and exceed client deadlines and offers personalized, proactive, and friendly client service.