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SERVICES » Pharmaceutical Development » Partnerships
The ABC Difference

 

Pharmaceutical Development

Biotech Services
Method Development & Validation
Stability & Release Testing
Analytical Support
Biomarker Panel Analysis
Peptide Mapping

DMPK and Bioanalytical Solutions (GLP)
Method Development & Validation
In-vitro DMPK Services
In-vivo DMPK Services
Bioanalytical Testing

Radiolabeling and Synthesis Solutions
Radiolabeling with GLP Certification
CGMP Services
Phase 0 Development Support
       Management

CMC and QC Solutions (CGMP)
Method Development & Validation
Extractables/Leachables Studies
Trace Analysis & Structural Chemistry
Stability Programs and Release Testing

Drug Development Consulting

Environmental Assessments

Seamless Project Management
through Strategic Partnerships

Strategic Partnerships

ABC Laboratories offers its clients professional, streamlined program management through strategic partnerships with a select group of complementary service providers. Unlike a one-stop business model, ABC’s “network of experts” approach gives sponsors access to a team of authorities in their respective fields. ABC maintains relationships with companies that offer specialized or niche competencies, including cellular/subcellular and metabolism experts to support in-vitro studies, leading toxicology service providers, AAALAC-accredited facilities for preclinical ADME, a 14C parenteral formulation facility, world-class Phase I clinical sites, manufacturing, packaging and distribution vendors and a network of cooperator field testing sites.

Whether a study is conducted entirely on-site or in collaboration with others, you can rest assured that every project is managed according to well-defined, compliance-driven laboratory and business processes. Organizational independence provides a built-in system of checks and balances not always present in a full-service model . . . and since multiple parties are invested in ensuring project success, there’s an inherently greater focus on customer satisfaction. With ABC’s network of experts approach, you get the technical guidance, quality data and timely delivery you want from an outsourcing solution, without having to manage multiple vendor relationships. 

Services Provided through Partnerships

Hepatic, microsomal metabolism
Toxicology
     Acute Toxicity
     Subchronic and chronic general toxicology
     Sensitization
     Reproductive & developmental toxicology
     Neurotoxicology
     Safety pharmacology
In-life phase of preclinical ADME
In-vitro DMPK
     Metabolic stability, ID and profiling
     Cytochrome P450 inhibition & induction
     Cytochrome P450 reaction phenotyping
     Drug-drug interactions
     Protein binding
Phase I clinical trials
Large-scale synthesis of APIs and intermediates Cytotoxic compound synthesis
     High-potency compound synthesis
Manufacturing of drug product
Packaging, warehousing & distribution

 

Scientist Pipetting

ABC Laboratories' strategic partnerships approach gives sponsors access to a team of authorities in their respective fields.