Stability Testing CROs in United States

Global leader in drug delivery technologies and development solutions. Catalent provides formulation, development, and manufacturing services for pharmaceuticals, biologics, and consumer health products.

Biologics CDMO providing GMP manufacturing of viral vaccines, recombinant proteins, and gene therapy vectors from BSL-2/3 facilities, with particular expertise in infectious disease and oncology.

Global CDMO with 30+ years delivering development and manufacturing for biologics, cell therapies, viral vectors, and mRNA across US, European, and Asian facilities.

Contract research and manufacturing organization offering drug discovery, API synthesis, analytical development, and formulation services to global pharma and biotech.

Specialty bioanalytical and analytical CRO providing method development, validation, and sample analysis services for pharmaceutical and biotech companies pursuing FDA submissions.

Contract analytical laboratory providing USP dissolution testing, method development, and stability studies for solid oral dosage form characterization under FDA guidelines.

San Diego-based CDMO providing small and large molecule API manufacturing, oligonucleotide synthesis, and ADC conjugation services from pre-clinical through commercial scale.

CDMO providing custom API development and manufacturing, solid dose and sterile formulation, analytical testing, and clinical and commercial supply from multiple US facilities.

US-based contract pharmaceutical company providing tableting, encapsulation, powder blending, packaging, and clinical supply manufacturing services for oral solid dosage forms.

GLP-compliant bioanalytical CRO with 25+ years of LC-MS/MS and GC-MS/MS expertise supporting preclinical-to-clinical drug development from purpose-built facilities.

Gene therapy and viral vector CDMO in Columbus, Ohio, with 20+ years of leadership and 500+ GMP drug substance batches produced for rare and ultra-rare disease programs.

Leading CDMO providing API development and manufacturing services including custom synthesis, generic APIs, and advanced intermediates from facilities across the US and Europe.

Labcorp's contract development and manufacturing arm providing formulation development, analytical services, stability testing, and clinical trial manufacturing for small molecules and biologics.

Leading analytical and testing laboratory providing stability testing, extractables and leachables, raw material testing, and method development for pharmaceutical and food industries.

CDMO offering integrated drug discovery, development, and manufacturing services including API production, drug product manufacturing, and analytical services from facilities in the US, Europe, and India.

US CDMO providing drug substance manufacturing, fill-finish, and device assembly services for biologics, vaccines, and cell/gene therapy products.

CDMO division of Eurofins providing process development, analytical development, and GMP manufacturing for biopharmaceutical products including monoclonal antibodies and recombinant proteins.

Top-tier biologics CDMO offering cell culture, microbial fermentation, and cell and gene therapy manufacturing across US sites supporting 128+ regulatory approvals.

CRO providing integrated drug discovery and development services including ADME/PK, bioanalytical, CMC, and clinical services with operations in the US and China.

Analytical services CRO specializing in subvisible particle characterization, aggregation analysis, and container closure integrity testing for biologics and pharmaceutical products.

US biologics CDMO providing cell line development, process development, cGMP manufacturing, and analytical services for monoclonal antibodies, recombinant proteins, and gene therapy products.

Specialist topical and transdermal formulation development CRO and CDMO offering dermal PK, in vitro permeation, bioequivalence, and formulation development services.

North Carolina-based CDMO specialising in oral solid dosage formulation development, analytical services, and cGMP clinical supply manufacturing for Phase I-III.

Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.

Premier provider of sterilization validation, microbiology, and biocompatibility testing services for medical devices. Part of Sotera Health, serving the global healthcare industry.

Specialized CDMO focused exclusively on sustained-release long-acting injectable formulation development, aseptic fill-finish, and lyophilization.

US-based contract analytical laboratory providing GMP/GLP method development, validation, stability testing, and extractables/leachables studies for pharmaceutical and biotech sponsors.

San Francisco Bay Area testing laboratory providing biocompatibility, extractables/leachables, sterility, and microbiology testing for medical devices and pharmaceutical products.

Bioanalytical and testing laboratory in the San Francisco Bay Area providing biocompatibility testing, extractables and leachables, sterility, and analytical chemistry services for pharma and medical devices.

Specialty preclinical CRO focused on Asia-Pacific markets, providing preclinical safety assessment, pharmacology, and bioanalytical services for small molecule and biologic programs.

California-based cGMP testing laboratory providing raw material testing, stability studies, extractables/leachables, and method development for pharmaceutical and biotech clients.

Gene therapy-focused CDMO providing viral vector manufacturing for adeno-associated virus (AAV) gene therapies, acquired by Catalent to expand biologics capabilities.

Major global CDMO providing end-to-end pharmaceutical development and manufacturing services including drug substance, drug product, and commercial manufacturing under the Thermo Fisher Scientific umbrella.

Missouri-based CDMO providing oral solid dosage development and manufacturing including tablets, capsules, sachets, and effervescent forms from R&D through commercial scale.

Translational pharmaceutics CRO/CDMO uniquely combining formulation development and clinical pharmacology under one roof, accelerating drug development timelines by running formulation and clinical testing simultaneously.

US-based biomanufacturing CDMO founded in 2020 delivering end-to-end development and manufacturing for biologics, mRNA, and cell and gene therapy across a domestic facility network.

Specialist bioanalytical, biomarker, and analytical sciences CRO with 500+ experts providing FDA/EMA-inspection-ready regulated bioanalysis across the US, UK, and Australia.

Contract research organization providing discovery, preclinical, and development chemistry services including API synthesis, safety pharmacology, and medicinal chemistry.

Global CDMO with integrated small molecule, biologics, and gene therapy manufacturing including proprietary viral vector platforms across the US, Europe, and Asia.

Global clinical supply packaging and distribution company providing clinical trial materials management, packaging, labeling, and worldwide distribution from facilities in the US and Europe.

Indiana-based aseptic fill-finish CDMO specialising in small-batch sterile injectable manufacturing for cell therapies, gene therapies, and biologics.

WuXi AppTec's cell and gene therapy division providing GMP viral vector manufacturing, cell therapy manufacturing, and plasmid DNA production from US and China facilities.