AAI Pharma Inc.

Company Overview
AAIPharma Inc. has more than 25 years’ experience in drug development and offers product development and support services to pharmaceutical, biotechnology and medical device companies worldwide. Our broad range of services is integrated across the drug development continuum, providing drug development solutions in pharmaceutical, analytical, bioanalytical, clinical and regulatory affairs services.

Quick Facts
AAI Pharma Inc.
2320 Scientific Park Drive
Wilmington, NC 28405

Featured Solutions

• Development and validation of in-vitro assay for the release of estrogen from... by AAI Pharma Inc.
  This white paper by AAI Development Services explains the development and validation of an in-vitro release method for determination of the release of Estrasorb from a lotion.
  
  
• Strategies for HPLC method development and validation for pharmaceutical ... by AAI Pharma Inc.
  This white paper by AAI Development Services points out challenges with combination products and offers points in developing and validating analytical methods including HPLC.
  
  
• Pharmacokinetics of orally administered pyridoxamine dihydrochloride in Type ... by AAI Pharma Inc.
  AAI Development Services reports on studies to evaluate the safety, tolerability and pharmacokinetics of oral Pyridorin in patients with Type 1 diabetes and diabetes-associated nepropathy.
  
  
• Quantitative determination of DHA-paclitaxel in human plasma using LC-MS-MS ... by AAI Pharma Inc.
  In this conference paper, researchers at AAI Development Services describe how they developed and validated a new method for quantitation of DHA-paclitaxel in plasma using a more stable sodium adduct, as well as liquid chromatography, tandem mass spectrometry and a mobile phase switching system.
  
  
• Quantitative determination of ketoprofen in human plasma by liquid ... by AAI Pharma Inc.
  This white paper describes how AAI Development Services developed and validated a rapid and sensitive bioanalytical method to determine human plasma concentration levels of ketoprofen, a non-steroidal anti-inflammatory agent.
  
  
• Understanding and implementing efficient analytical methods development and ... by AAI Pharma Inc.
  This white paper by AAI Pharma describes the development and validation process for investigational new drug, new drug and abbreviated new drug application submissions, and advances in analytical methods development and the validation process.
  
  

• Analytical services: Pharmaceutics, bioanalysis, biostatistics, GC, ... by AAI Pharma Inc.
  AAI Pharma Inc. offers analytical services including pharmaceutics, bioanalysis, biostatistics, GC, microbiological and stability services.
  
  
• Manufacturing services: Sterile liquid, lyophilized and solid dose, by AAI ... by AAI Pharma Inc.
  AAI Pharma Inc. offers product development and manufacturing support services to pharmaceutical, biotechnology and medical device companies.
  
  
• Product development services: Biotechnology, drug delivery, formulation and ... by AAI Pharma Inc.
  AAIPharma Inc.offers product development and support services and provides drug development solutions in pharmaceutical, analytical, bioanalytical, clinical and regulatory affairs services.
  
  
• Regulatory services: Regulatory, medical, QA/QC and validation, by AAI Pharma... by AAI Pharma Inc.
  AAIPharma Inc. has more than 25 years’ experience in drug development and offers product development and support services to pharmaceutical, biotechnology and medical device companies worldwide. Our broad range of services, including regulatory affairs, is integrated across the drug development continuum.
  
  
• Clinical services: Monitoring, phases I-IV and data management, by AAI Pharma... by AAI Pharma Inc.
  AAI Pharma Inc. clinical services include phases I-IV studies for drugs, biologics and devices, clinical trial material manufacturing and distribution, monitoring and site management, data management, statistical analysis and pharmacovigilance.
  
  
• Pharmaceutical Analytical Services by AAI Pharma Inc.
  AAI Pharma's pharmaceutical analytical services provide more than just testing, but are in accordance with regulatory compliance, using modern methods and SOPs in all areas: from raw material and active ingredient testing to stability and compendial testing.
  
  
• International Clinical Services by AAI Pharma Inc.
  AAI Pharma's international clinic services offer investigator recruitment and quality monitoring for successful clinical trials.
  
  
• Data Management by AAI Pharma Inc.
  AAI Pharma's data management systems are capable of electronic data capture, database development and programming, CRF design, data entry and validation, coding, custom reporting and data extraction, and SAE reconciliation.
  
  
• International Clinical Services : Biostatistics by AAI Pharma Inc.
  AAIPharma's International Clinical Biostatistics Services offers full statistical support and analysis, Phase I through IV statistical analysis planning, statistical reports, and statistical programming for clinical trials.
  
  
• Biotechnology product development by AAI Pharma Inc.
  AAIPharma’s Biotechnology group offer solutions and strategy from concept to NDA for biotechnology companies worldwide, regardless of size, to accelerate and expand their product development capabilities without sacrificing the capital and time required to maintain a complex infrastructure.
  
  
• Drug Delivery Technology by AAI Pharma Inc.
  AAIPharma’s Research and Development group focuses on improving the pharmacokinetics of a drug by developing technologies, processes, expertise, and intellectual property intended to improve a products efficacy, safety, and patient compliance.
  
  
• Formulation Development by AAI Pharma Inc.
  AAI Pharma's formulation services can help develop solutions; lyophilized injectables; oral liquids; solids formulations of oral capsules; immediate or modified-release tablets; or topicals to meet company needs and that of the marketplace.
  
  
• International Generic Product Development by AAI Pharma Inc.
  In today’s generic market, time to launch and product pipeline are key determinants to success. AAIPharma's Generic Product Developmentgroup works as a partner throughout the drug development process.
  
  
• Medical Guidance and Safety Surveillance by AAI Pharma Inc.
  AAIPharma's Medical Affairs services offer counsel and guidance on feasibility assessments, clinical development plans, therapeutic training and guidance, study design and protocol development, clinical study reports, and post marketing surveillance.
  
  
• Drug Exploration by AAI Pharma Inc.
  AAI Pharma's drug characterization and structural confirmation services offer X-ray single crystal analysis, mass spectral analysis (MS), full range of 2D and 3D nuclear magnetic resonance (NMR) analyses, fourier transform infrared spectroscopy (FTIR), and elemental microanalysis.
  
  
• Routine Testing Services: Raw Materials and GC Analysis by AAI Pharma Inc.
  AAI Pharma offers routine testing of a variety of active pharmaceutical ingredients (APIs) and raw materials/excipients.
  
  
• Phase I-IIA Clinical Pharmacology Services by AAI Pharma Inc.
  AAIPharma's Phase I-IIA Clinical Pharmacology services offer experienced research teams of physicians, nurses, technicians and CRAs, rapid subject recruitment, healthy volunteers as well as special populations, a focus on volunteer and patient safety, regulatory compliance, and strict adherence to the protocol.
  
  
• Phase II-IV Clinical Trials Services by AAI Pharma Inc.
  AAIPharma's Phase II-IV Clinical Trials services offers highly qualified clinical research teams including project managers, physicians and scientists, clinical research associates (CRAs), biostatisticians, data managers, medical writers, quality and regulatory specialists, working relationships with a network of study sites around the world, and eClinical technologies to assure critical path efficiencies.
  
  
• Quality Control/Quality Assurance by AAI Pharma Inc.
  AAIPharma has compiled a history of successful GMP, GLP, GCP audits and Pre-Approval Inspections (PAIs).
  
  
• Microbiological Analysis Services by AAI Pharma Inc.
  AAIPharma's Microbiological Analysis services provides microbial method development and validation, and performance of methods used to monitor the conditions of GMP manufacturing environment and the quality of manufactured products..
  
  
• Regulatory Affairs Services by AAI Pharma Inc.
  AAIPharma’s Regulatory Affairs group works as a partner, and an active participant throughout the development process from the pre-IND meeting through the NDA approval process, and beyond.
  
  
• Mercury Lab Test Quote Estimator by AAI Pharma Inc.
  AAIPharma’s Routine Testing Laboratory introduces its new automated quote generation system on the web, Mercury.
  
  
• Solid Dose Manufacturing for Clinical or Small-Scale Commercial Manufacturing by AAI Pharma Inc.
  Many pharmaceutical companies have come to rely on AAIPharma’s solid dose manufacturing capabilities to get their critical clinical trial materials manufactured, packaged, labeled and distributed to the investigator sites on time.
  
  
• Stability Storage and Analysis by AAI Pharma Inc.
  AAIPharma's Stability Storage and Analysis Services offer ICH and customized storage conditions, handling of controlled substances, highly toxic compounds and antibiotics, photo-stability studies (option 1 and 2), freeze/thaw cycle studies, over 17,500 cubic feet of storage space, locations in Wilmington, NC and Neu Ulm, Germany, computerized protocol generation, and state-of-the-art monitoring.
  
  
• Sterile Liquid and Lyophilized Manufacturing Services by AAI Pharma Inc.
  AAIPharma's sterile liquid and lyophilized manufacturing services offer formulation sevelopment for sterile products, preformulation, product development, process development, solutions, emulsions, suspensions, powders, lyophilization, analytical services, compendial testing, and much more.
  
  
• Regulatory & Qualification Validation Services by AAI Pharma Inc.
  AAIPharma's Regulatory & Qualification Validation Services offer a validation master plan, project management, installation, operational, and performance qualification, protocol execution, process, cleaning, and design validation, software qualification, standard operating procedures, and much more.
  
  
• AAIPharma Services Offerings by AAI Pharma Inc.
  AAIPharma is a provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries. They offer a range of services including analytical, bioanalytical, clinical, and pharmaceutical services.