GXP 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.

Examples of our consulting services:

Biotechnology

  • Assisted in qualification of pilot plant facility
  • Conducted training sessions in GLP and GMP practices for R&D personnel
  • Implemented quality systems for start-up company
  • Performed internal and external audits for cGMP compliance
  • Provided manufacturing support for clinical production
  • Served in QA and manufacturing management roles
  • Validated laboratory equipment for analytical testing
  • Investigated and resolved non-conformances and implemented CAPAs
  • Assisted with resolving outstanding customer complaints
  • Set up QA department, prepared SOPs, and managed audit program
  • Set up environmental monitoring program and developed supporting SOPs

Medical Device | In-Vitro Diagnostics

  • Developed and implemented a preventative maintenance program
  • Developed and documented a Risk Management Plan, and conducted the Hazard Analysis, FMECA, and FTA
  • Provided regulatory support for 510k filing
  • Developed a strategy for handling combination product FDA requirements late in the development cycle, and wrote compliance documentation
  • Established quality systems for device manufacturing
  • Implemented corrective actions (CAPA) based upon FDA warning letter citations
  • Prepared and implemented QSR training program for combination products
  • Developed and executed validation protocols and prepared the reports
  • Performed internal audits per QSRs, identified system deficiencies and assisted with corrective actions

Pharmaceutical

  • Assisted in PAI preparation by reviewing technical data and training personnel in FDA response techniques
  • Assisted with Drug Master File preparation
  • Facilitated remediation of FDA warning letter citations
  • Validated manufacturing, lab, and process equipment, software, and hardware
  • Implemented quality systems for clinical and commercial manufacturing
  • Performed GCP monitoring and conducted audits at clinical sites
  • Performed over 100 audits annually of suppliers, contractors and clients
  • Established quality systems and served as QA manager/director for virtual companies
  • Wrote investigation reports for deviations and non-conformances
  • Acted as QA Director
  • Performed customized and general GMP and compliance training