GXP Remediation, Advice & Suport

Excellence in Pharmaceutical Consulting

We specialise in helping pharmaceutical, biotechnology, hospital manufacturing services, and Clinical Trial Sponsors to achieve and maintain regulatory compliance and excellent pharmaceutical quality systems, to best industry standards.

Ensuring Product Quality and Patient Safety through sustainable GXP compliance

Our prime mission is to improve and protect public health by providing the best quality GXP advice and support to the pharmaceutical industry using the best quality consultants.

We offer bespoke expert support tailored to your specific business, licensing, and GXP regulatory needs, from responding to specific questions and non-conformances to guiding post-inspection remediation. As former regulators we ensure your response to compliance issues and adverse inspection findings is risk based, thorough and effective. cycle.

Flexible and bespoke to meet your specific needs

Our client’s range in size, sector, and maturity. The one thing they have in common is a desire to partner with pharmaceutical experts who offer bespoke support tailored to their specific pharmaceutical, licensing and GXP regulatory needs including:

Remote consultancy support providing an opportunity to pose questions for specific regulatory or GXP compliance requirements and receive an expert viewpoint or perspective on a particular issue, deviation, manufacturing, wholesale dealers or clinical trial authorisation application query, or strategic compliance improvement activity.
Onsite consultancy visits offering a face-to-face collaboration for specific projects to provide expert experience and advice to help drive quality and GXP compliance improvements by providing considered recommendations based on regulatory expectations and industry best practices.
Bespoke GXP training courses offering both remote and in-person workshops and coaching, designed using expert experience and advice to help clients acquire knowledge and awareness of GXP regulatory requirements and drive quality and continuous improvements, for example support for establishing an effective self-inspection programme and training of auditors.

Giving you confidence and a pathway to achieve GXP compliance

Significant recent changes to GXP regulations and guidance together with a lack of expertise and experience can leave organisations at greater risk of poor compliance which in turn poses an increased risk to product quality and patient safety. Avoid reputational damage and possible regulatory action by putting your trust in a partner who brings clarity to complexity and assurance in action to your GXP compliance needs.

Why Choose EPiC for GXP Advice, Support and Guidance

Choosing EPiC for GXP remediation, advice and suppor means partnering with a team of seasoned experts who bring a wealth of experience as former regulatory inspectors. Our deep understanding of GXP compliance challenges, combined with our tailored, practical solutions, ensures that your organisation is well-equipped to meet regulatory requirements and maintain high standards of quality.

Next Steps

Ready to elevate your GXP compliance efforts? Contact EPiC today to learn more about our expert pharmaceutical consultancy services, and comprehensive remediation support and guidance. Let us help you achieve compliance and ensure the highest standards of quality in your pharmaceutical operations. Reach out now and take the first step towards a more compliant and successful future!