Biocompatibility, Sterility & Packaging Validation

Compare vendors for biocompatibility, sterility & packaging validation within Medical Device Development, Testing & Manufacturing, covering Biocompatibility Testing, Extractables & Leachables Testing, Sterility Assurance & Microbiology Testing, Sterilization Services….

Capabilities in this workflow

Vendors supporting this workflow

Frontage Laboratories is a CRO and CDMO providing bioanalysis, DMPK and ADME studies, toxicology, Phase I support, and drug manufacturing.
Evidence-backed workflow match
Matches Extractables & Leachables Testing
“Extractable/Leachable (E/L) study for drug product container/closure”
Source: frontagelab.com

Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more

Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.

Products: Acceleration Platform

Evidence-backed workflow match
Matches Sterilization Services
“Terminal sterilization services from Altasciences deliver sterility assurance for parenterals, ophthalmics, and other pharmaceuticals under cGMP standards.”
Source: altasciences.com

Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more

Inotiv is a CRO and research models provider offering toxicology, in vivo pharmacology, research and transgenic models, bioanalysis and DMPK.

Products: Teklad, Target Sufficiency +1 more

Evidence-backed workflow match
Matches Biocompatibility Testing
“Our team of board-certified medical device pathologists utilizes advanced techniques and methodologies to evaluate the biocompatibility, safety, and/or efficacy of medical devices…”
Source: inotiv.com

Also offers: Toxicology Studies, In Vivo Pharmacology & Efficacy Models, +3 more

Favicon of DCN Dx

CDMO / CMO · +5 more types

DCN Dx is an IVD CDMO and CRO providing assay development, clinical trial operations, regulatory support, and manufacturing services.

Products: miniDxR, MICA-200C +1 more

Evidence-backed workflow match
Matches Sterility Assurance & Microbiology Testing
“DCN Dx performs sterility testing to confirm the absence of viable microorganisms in aseptically manufactured products, supporting regulatory and quality standards.”
Source: dcndx.com

Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more