AAIPharma is a global provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries. From a single test through a range of integrated service offerings, we create value to an industry in search of productivity and innovation.

We are AAIPharma, a company dedicated to partnership and team work, a company that pairs the best of AAI to the needs of Pharma: the customers we serve today and will serve tomorrow.

Pharmaceutical

• Candidate selection and characterization
• Formulation feasibility studies
• Technology transfer
• Process validation
• Toxicology supply manufacturing, packaging and labeling
• Clinical supply manufacturing, packaging and labeling
• Small scale commercial manufacturing
• Preformulation and formulation
• Proprietary drug delivery systems

Analytical

• Compendial microbiology testing
• Microbiological isolate speciation
• Method development, refinement and validation
• Protein and peptide analysis and characterization
• N-terminal sequencing and amino acid analysis
• Raw material testing
• Active pharmaceutical ingredient testing
• Cleaning validation
• Stability testing and storage
• Environmental monitoring and support

Bioanalytical

• Bioanalytical testing by LC/MS/MS, GC/MS, ICP/MS, HPLC, electrophoresis, radiochemistry & immunoassays
• Metabolite profiling and mass balance assessment
• Pharmacokinetic and pharmacodynamic screening
• Mammalian cell-based assays, biomarker and CYP 450 analysis
• Method development and validation

Clinical

• Phase I-IV studies for drugs, biologics and devices
• First-in-man studies
• Strategic planning and project management
• Protocol feasibility and investigator recruitment
• Clinical trial material manufacturing and distribution
• Monitoring and site management
• Medical management and medical writing
• Data management and statistical analysis
• Pharmacovigilence
• E-clinical

Contact Information

AAIPharma Inc.

2320 Scientific Park Drive
Wilmington, NC 28405 USA
Phone: 800-575-4224 / 910-254-7000
Fax: 910-815-2300
E-mail:

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