Expert Consultants
Find the right consultant for your business
World Class Compliance Support
Advice you can rely on
Extensive Industry Experience
Many ex-regulatory inspectors

Our Services

WE SPECIALISE in helping pharmaceutical and biotechnology companies, as well as other associated healthcare clients, to achieve and maintain regulatory compliance and excellent pharmaceutical quality systems, to best industry standards.

Mock Regulatory Inspections

Former regulatory Inspectors can perform mock EMA, EU, MHRA or FDA inspections to assess the readiness of a company to successfully host a regulatory inspection, or as part of an initial gap analysis as a site embarks on preparation for such an inspection.

Advice, Support & Guidance

EPIC Auditors has a broad range of experience across all aspects of the product lifecycle. This includes supporting new companies during the initial stages of product development into clinical trials, through commercial manufacture and distribution to advising on post marketing commitments and pharmacovigilance.

Remote Audits

During the Covid 19 pandemic, like the MHRA, and like many other businesses, EPIC Auditors has been providing remote support and auditing.  Helping companies to meet the regulatory requirements and to develop the quality systems essential to support much needed clinical trials for various Covid 19 treatments.

Our Latest Projects

EPIC Auditors have extensive global experience auditing within Europe, the USA, Puerto Rico, India and China. Audits in all parts of the World will be considered.

In-depth System Reviews
In-depth System Reviews

We have been working with two large UK based pharmaceutical manufacturers conducting in depth reviews of their pharmaceutical quality systems. In contrast to an audit which involves sampling documents and records these reviews focus on a particular system, process or procedure with the goal of assessing it in detail against regulatory guidance and expectations.

Support for Overseas Manufacturers
Support for Overseas Manufacturers

We are working with an overseas manufacturer who wants to supply medicinal products to the UK and Europe. Starting with a gap analysis of the companies Pharmaceutical QS, improvements will be made to meet EU GMP requirements. A mock EU GMP inspection will then be performed prior to the company triggering a regulatory inspection.

Routine Compliance Audits
Routine Compliance Audits

Many clients request regular compliance audits of their facilities and systems in order to supplement their own internal audits and attain an independent assessment. Audits are conducted against EU GMP and GDP with any deficiencies and opportunities for improvement being highlighted. EPiC’s consultants can assist with implementation of corrective and preventative actions.

Qualified Person Services
Qualified Person Services

Many of EPiC’s consultants are eligible to act as a Qualified Person and we have contract QP’s supporting a number of licenced manufacturers certifying products prior to release to the market.

Testimonials

See what our clients say about us and our services.

Mark King

"The team at EPiC are GxP leading experts and have first hand experience of how different competent authorities work and industry best practice. We have consistently found them to be incredibly professional and to deliver against our requirements as well as providing really helpful additional insights."

Mark King Senior Director Quality Operations ( QP / RP) Accord Healthcare

What do you require?

How can we help your business? Our global auditing service can be tailored to meet client’s needs.