Our cGMP analytical laboratories located in Research Triangle Park and Wilmington, NC have over 30 years of experience in providing comprehensive analytical services in support of Pharmaceutical Product Development and Manufacturing for clinical trial supply and commercial programs. The analytical organization is structured into groups with specific focus on:

• Analytics for Small Molecules
• Biopharmaceuticals/Biotechnology Products
• Physical Chemistry and Material Characterization
• Stability Programs
• Compendial/Raw Material testing
• Microbiological Services

The advantages of using the AAIPharma Services

• Impeccable Long Term Compliance Record
• Motivated, Experienced (average of 10+ years) Full Time Staff with Outstanding Communication Skills
• Outstanding Technical Expertise (Staff includes 12 Ph.D. and over 35 M.S. Scientists)
• Dedicated Project Management
• Comprehensive Services and Experience working with a
• Wide Variety of Excipient, API and Drug Product Forms
• Large Organization (over 200 staff, over 120 LCs)
• Fixed Cost, Hourly or Flexible/Adjustable FTE Programs including In-Sourcing Agreements

We Offer:

• Method Development and Validation (Assays, Related Substances, Stability Indicating Methods, Chiral, Dissolution, Preservative, Minor Component, Cleaning
• Methods, Residual Solvent Methods, Microbial Methods)
• Method Life Cycle Evaluation and Revalidation
• Isolation and Identification of Impurities
• QC Testing, Extractable/Leachable Studies
• Heavy Metal/Trace Metal Analysis
• Residual Impurities and Contaminants (Residual Antibiotics, Process Enhancing Compounds, Surfactants, Antifoaming Agents, Melamines)
• Wet Chemistry
• Moisture Testing, Thermal Analysis
• Polymorph Characterization
• Salt Selection
• Particle Size Characterization
• Cell Based Bioassays
• Protein, Peptide Oligonucleotide and Oligosaccharide Characterization, Sterility Testing, USP, EP and JP Testing

AUTOMATED QUOTE GENERATOR FOR RAW MATERIALS!

MERCURY

AAIPharma Services' Compendial Testing Laboratory automated quote generation system is a web portal that enables you to generate your own raw material and microbiology testing Service Estimates. The system is simple, fast and accurate and provides flexibility over the quote generation process. Our staff has experience with a variety of synthetic and biopharmaceutical compounds (APIs), finished product dosage forms and delivery systems such as tablets, capsules, soft gel capsules, pellets, parenterals, lyophilized products, suspensions, emulsions, creams, ointments, trans-dermal systems, medical devices and medicated feeds. We have expertise in a broad range of analytical techniques and types of equipment. AAIPharma Services develops analytical methods for drug substances, intermediates and drug products for batch control and stability testing as well as for new drug applications/registrations. Types of analyses include identity, purity, content and dissolution assays according to different registration requirements, CPMP/ICH regulations and customized requests. A variety of cleaning methods (swab or rinse sampling techniques, using a UV, GC or HPLC test methods) can also be developed to support the manufacturing environment. Residual active and cleaning agent testing is also available. Validations are conducted according to a written protocol pre-approved by the customer and AAIPharma Services before project initiation. At AAIPharma Services, our analytical labs are an extension of your organization.Our goal is to provide you with the highest service levels in the industry.