Consulting Services



MWA offers a full range of GXP consulting services, including GCP, GLP, and GMP compliance. We provide consulting expertise from development through commercialization for the pharmaceutical, biotechnology, and medical device industries. Our experienced associates work closely with clients with a hands-on approach to develop phase-appropriate Quality Management Systems that are compliant with current regulations, standards and guidelines, yet avoid the pitfalls of implementing too much, too soon. We perform audits, assist with pre-approval inspection preparation, provide regulatory support, assist with process, utility, and facility validation, provide CMC analytical, formulation, manufacturing, and quality services, along with other regulatory compliance support services.

Service Area Examples:


  • Qualification support for pilot plant facilities
  • Training sessions in GLP and GMP practices for R&D personnel
  • Implement quality systems
  • Internal and external audits for cGMP compliance
  • Manufacturing support for clinical production
  • QA and manufacturing management roles
  • Validate laboratory equipment for analytical testing
  • Investigate and resolve non-conformances and implemented CAPAs
  • Customer complaints support
  • Set-up QA department, preparation of SOPs, and management of audit program
  • Establish environmental monitoring program and development of supporting SOPs


  • PAI preparation, including reviewing technical data and training personnel in FDA response techniques
  • Drug Master File preparation support
  • Facilitate remediation of FDA warning letter citations
  • Validate manufacturing, lab, and process equipment, software, and hardware
  • Implement quality systems for clinical and commercial manufacturing
  • Perform GCP monitoring and audit support at clinical sites
  • Performance of over 100 audits annually of suppliers, contractors and clients
  • Establish quality systems and serve as QA manager/director for virtual companies
  • Author investigation reports for deviations and non-conformances
  • At-interim QA Director role
  • Perform customized and general GMP and compliance training

Medical Device | In-Vitro Diagnostics

  • Develop and implement preventative maintenance program
  • Develop Risk Management Plan, and conduct Hazard Analysis, FMECA, and FTA
  • Provide regulatory support for 510k filing
  • Strategy development for handling combination product FDA requirements late in the development cycle, and wrote compliance documentation
  • Establish quality systems for device manufacturing
  • Implement corrective actions (CAPA) based upon FDA warning letter citations
  • Prepare and implement QSR training program for combination products
  • Develop and execute validation protocols and prepared the reports
  • Internal audit support per QSRs, identification of system deficiencies and assistance with corrective actions