Summary Technical Consulting and Support: 

Pharmaceutical, Biotechnology, Medical Device, Drugs, Diagnostics, Cell Therapy, Radio-pharmaceutical, Pre-clinical and Clinical Products consultancy and support in the following areas:

  • Remediation of FDA's Form 483, Warning Letters, Consent Decree Quality and Compliance Findings.
  • Quality Control and Raw Materials Testing.
  • Microbiological, Quality Control, Analytical, Bioassay and Immunology Testing Support.
  • Biocompatibility and Sterilization Testing Support.
  • Quality Assurance and Engineering Support.
  • Process, Cleaning, Equipment, Method and Facility Validation.
  • Routine and Validation of Ethylene Oxide, Gamma, Vaporized Hydrogen Peroxide, Dry Heat and Steam and Radiation Sterilization Processes.
  • Sterility Assurance, Contamination Control, and Aseptic Processing Requirements.
  • Production/Process Control Requirements.
  • Quality Systems, and Compliance Requirements.
  • Manufacturing Processes, Optimization and Development.
  • Technical Writing of Protocols, Reports, Standard Operating Procedures (SOP) or Standard Test Method (STM).
  • Quality Assurance Batch Records, Document Review and Product Release Requirements.
  • Technical Writing of Standard Operating Procedures (SOPS) and Standard Test Methods (STM).
  • Technical Writing of Validation Protocols and Reports.
  • Technical Writing and Review of Quality Investigations (CAPA, OOS, Invalid Assays, Deviations, Environmental Monitoring Testing Excursions).
  • Product Complaint Handling and Investigations.
  • Technical Review of Quality Investigations, Validation Protocols, Reports, Procedures.
  • Aseptic Processing and Aseptic Simulation Support.
  • Stability Testing Program (Design through Shelf Life/Expiration Dating and Data Management).
  • Process Development, Research and Development and Product Design Support.
  • Utilities (Pharmaceutical Water and Gases) Design, Validation Testing and Data Management.
  • Cleanroom Design, Validation, Testing Services and Maintenance.
  • Product Manufacturing Support Services (Fill Finish Support).
  • Pre-clinical and Clinical Trials Support Services (Phase I, II, III and IV).
  • Contract Manufacturing Organization (CMO) Support Services.
  • Contract Research Organization (CRO) Support Services.
  • Contract Testing Laboratories (CTL) Support Services.
  • Research & Development (R & D) and Process Development (PD).
  • Technical and Product Specifications.
  • Regulatory Affairs Technical Writing, Review, Filing and Support.