Science

and

FDA & Industry Quality Consulting

Science & Compliance Experts

About Us

Welcome to 5Ws GxPertise, where our passion for all consumers of pharmaceutical products, devices, and biologics drives our commitment to providing exceptional quality consulting and expertise. Founded in 2014, we have evolved from a small startup by a retired FDA investigator into a dynamic and innovative quality consulting company with a focus on the GxPs for regulated industries. Our group of consultants have years of experience in quality and operations in the pharmaceutical industry, medical devices and combination products, biologics, food, and cosmetics.

Our Mission

At 5Ws GxPertise, We believe that in order to best serve the consumer, we must help our Clients enhance their quality mindsets through education, auditing, quality system and regulatory compliance related project-based work, and remediation when necessary. We aim to help companies build their brand and reputation by partnering with our clients to support them as they grow. We want to promote longevity of a company’s operations by providing the services they need, when they need them.

What sets us apart

Our goal is to focus on both Science and Compliance. Both must work hand in hand to effectively provide a quality product at a sustainable cost. We understand the relationship between design and manufacturing, and how they must work together. We vet and challenge our experts to ensure that our Clients are getting the best resources for their projects.

We are excited to have you join us on our journey to grow the quality mindset. Whether you are a Client, affiliate, or someone interested in our work, we invite you to explore 5Ws GxPertise and be part of our story.

Services

  • Our experts have years of experience in the FDA and Industry (Globally) for all areas of GxP (GMP, GCP, GLP, etc.), from Clinical to Commercial, and Design development to Post market surveillance.

    We perform routine internal “maintenance” audits for clients, third party audits, Mock PAI, For cause audits, group audits on behalf of clients, and what we like to call our “Deep Clean” audits to fully prepare you for the toughest health authority inspections.

  • If you are in need of training and education of employees to enhance their understanding of quality systems and regulatory requirements, we can create a custom solution for you and your team, or utilize one of our standard training programs.

  • Be it short-term or long-term projects, we possess expertise across various project types and the necessary resources to provide assistance.

    For example:

    • QMS development

    • Validation/Qualification program development

    • Regulatory submissions

    • Internal Audit Program development

    • Regulatory Reference Guidance

  • Global Regulatory knowledge is a focal point of our experience. We provide support and review of responses to observations or Warning letters as well as aid in implementing response actions and improvements.

  • We also can assist with:

    • FDA Annual Registration (21 CFR 207)

    • DEA Audits

    • Food Safety Audits

    • Cosmetic Audits

    • FDA Meeting Support

    • Staff Augmentation

    • Maintenance Audits

    • Improving & Enhancing overall Quality System and Regulatory Compliance

CONTACT

To learn more about our services and objectives or express your interest, kindly enter your email below and fill out the contact form.

We will be in touch as soon as possible.