Consulting Expertise in Quality Systems and GXP Compliance

Call 866-497-7787

MWA: Quality With Vision

MWA shares your commitment to GXP quality and regulatory compliance. As a leader in GXP compliance consulting services, we aim to provide excellence in innovative and holistic solutions to the pharmaceutical, medical device, and biotechnology industries. We offer a full range of services in GCP, GLP, and GMP compliance from development through commercialization. We set high standards of excellence in all aspects of the business with a focus on establishing and maintaining strong partnerships and producing exceptional results.

Our Services

GXP Auditing & Gap Assessments

  • Supplier/Contract Service Provider Audits (CMO, CRO, CTL, Software, etc.)
  • Sponsor Audits and Services
  • PAI and BIMO Auditing, Preparedness, Training
  • Clinical Trial Audits
  • Protocol and Investigator Brochures (IB) Review
  • Regulatory Submission Document Review and Audits
  • Trial Master Files (TMF) Audits
  • Medical Device Quality Systems (MDSAP, MDR, or FDA Pre-assessment)

Quality Systems & Operations

  • Data Integrity
  • Validation and Qualification
  • Quality Assurance (Batch Record Review, SOP development, etc.)
  • Quality Management Systems Support & Development
  • Quality Remediation
  • Management and Design Controls
  • Risk Management
  • Project Management
  • Manufacturing Compliance Oversight
  • Manufacturing Engineering and Support

Laboratory Controls

  • Analytical/Quality Control (QC) Support
  • Clinical and GLP Support
  • Analytical Methods Development
  • Microbiology Support

GXP Regulatory Inspection Support & Training

  • FDA-483 and/or Warning Letter Response & Remediation
  • Inspection Support and Facilitation
  • Mock GXP Regulatory Inspections
  • GDP, GLP, GCP and GMP  Training

Additional Services

MWA’s highly qualified associate base possesses a broad spectrum of expertise across the life sciences, worldwide. We match our clients with knowledgeable, delivery-oriented personnel on initiatives throughout the field. Contact us to find out how we can assist you.

GXP Compliance Consulting

Experience the difference in the customer focus and quality in partnership with MWA Consulting. Our response in meeting client needs, from urgent support requirements to strategic planning and execution, is parallel to none.

We have been in the industry for over 25 years, working with our clients in achieving success. We stand by you to support the overall quality needs of your organization. Let’s build quality by design together.

Testimonials

“We are right on target to launch our electronic Quality Management System in October which [MWA consultant] is key and instrumental. We couldn’t have done it without her support.”

– Client Testimonial, 2018

“The [audit] findings are very well documented. [MWA Consultant’s] comments and judgments made  the findings more valuable in sense of process improvement. The audit [MWA Consultant] conducted should improve QMS management and lead to the goal we pursue a as Sponsor to receive reliable clinical trial data.”

– Client Testimonial, 2020

“Thanks again, and also wanted to mention I think MWA’s webinars are fantastic.  The presentations have been so thorough, and I have truly benefited from the ones I have attended.  Thanks greatly to you and your team!”

– Webinar Attendee Testimonial, 2019

“I had my first call with the [Client] team on Friday.  [Client Representative] was on the call and is a huge fan of your company.  Thought you should know. “ 

– MWA Consultant, 2020

“[MWA Consultant] has been performing wonderfully. She is proactive in supporting projects and has helped streamline our review process. She has been indispensable in reviewing all our artwork and documents needed for commercial launch.”

– Client Testimonial, 2018

“[MWA Consultant] has been excellent- very upfront about what she can do and extremely thorough in her review of material. We are extremely happy with having her as a consultant. Since its our first time doing GLP work, we are still figuring out what we need on our end, and [MWA consultant] has provided us with excellent support.”

 – Client Testimonial, 2017

Contact Us