Research & Delevelopment

USA Pharmaceuticals & Sports Science product development services are designed to speed commercialization.

USA Pharmaceuticals & Sports Science delivers comprehensive services from conception, through development, to scale-up manufacturing and commercialization. We are dedicated to cost-effectively accelerating our customers’ time to market. Since 1979, our extensive team of experienced scientists have been leaders in developing premium pharmaceuticals, over-the-counter drugs and dietary supplements for customers around the world.

USA Pharmaceuticals & Sports Science has adopted efficient formulation development to support your product development requirements:

• Analytical Testing
  
• Raw Material Testing
  
• Active Pharmaceutical ingredient testing
  
• Characterization of physical and chemical properties
  
• Compatibility studies
  
• Candidate selection
  
• Formulation optimization
  
• Methods Development, refinement, & validation
  
• Cleaning validation
  
• Stability testing and storage
  
• Environmental monitoring and support
  
• Feasibility studies
  
• Technology transfer
  
• Process validation
  
• Pre-formulation, formulation, and process development of multiple oral dosage forms
  
• Drug delivery systems
  
• Regulatory planning and consulting
  
• Review and counsel on clinical, CMC, and bioanalytical issues
  
• Submission assembly and preparation
  
• Planning for and representation at meetings with regulatory authorities
  
• Agency response preparation
  
• Regulatory and technical management
  
• A full range of instruments to support full monograph testing
  
• A full range of instruments to support excipient functionality characterizations
  
• Instrument, equipment, and facility qualification/validation

Analytical Development
USA Pharmaceuticals & Sports Science has developed analytical testing methods to meet all project specifications while ensuring rapid development. U.S. Food and Drug Administration (FDA)- and International Conference of Harmonization (ICH)-compliant processes include:

• Cleaning validation
  
• Method validation
  
• Dissolution profiling
  
• Forced degradation studies
  
• Stability studies

Our specialty is in providing turn-key solutions to our customer's needs; however we also offer the advantage of selecting services on an individual basis. Our analytical capabilities includes: methods development, refinement and validation, as well as, raw material / A.P.I and stability testing.

State-of-the-Art Technology
USA Pharmaceuticals & Sports Science utilizes top-of-the-line equipment for developing, sampling, and testing all finished goods. Our qualified staff makes use of the latest technology to create your unique brand for your business, with a diverse set of quantitative and qualitative capabilities:

Physical Testing

• Disintegration
  
• Particle Size
  
• Viscosity
  
• Color (Gardner Scale)
  
• Friability
  
• Microscopic Analysis
  
• Hardness
  
• Thickness

Analytical Lab

• HPLC
  
• UPLC
  
• UPLC-MS
  
• GC
  
• GC-MS
  
• UV-Vis
  
• FTIR
  
• NIR
  
• AA
  
• ICP-MS
  
• TOC
  
• Dissolution
  
• pH
  
• Moisture Analysis (Karl Fischer)

Microbiological Lab

• Conventional & Rapid Micro Detection

Development processing equipment include

Solids

• V - Blenders
  
• Twin Screw and Ribbon Blenders
  
• High-shear Granulation
  
• Fluid bed Granulation
  
• Roller compaction
  
• Film Coating
  
• Modified Release Film Coating

Our product development capabilities include pre-formulation, formulation and process development of multiple oral dosage forms. The department develops tablets and capsules of any dimension with a variety of characteristics such as:

• modified-release
  
• rapid release
  
• extended release
  
• bi-layers
  
• pellets
  
• mini tabs

Liquids
Development equipment allows for production of:

• Solutions
  
• Elixirs
  
• Suspensions
  
• Modified Release
  
• Energy Shots
  
• RTD’s (Ready to Drink) protein shakes