Audit & regulatory expertise in the pharmaceutical industry

AUNERIPHARM is your ideal partner for assessing and improving your preparation for inspections by regulatory bodies such as the EMA (European Medicines Agency), the FDA (U.S. Food and Drug Administration) or any other national and international authorities, coaching you through these inspections and supporting you in responding to any discrepancies.

About us

Whether you are a sterile or non-sterile facility, AUNERIPHARM offers you its expertise in the preparation, the coaching and the responses to non-conformities in inspections/audits.

Our team of experts has a perfect command of current international regulations and a team is defined according to the needs identified during our preparation audit.

Together, we define the most relevant staff to prepare and coach the inspection/audit.

To achieve this common goal, we carry out:

Audit / Inspection preparation

Evaluating the situation on site via a pre-audit
Preparing for the inspection through role-playing (presentation of deviations, field visits, assistance in drafting strategic documents, summary presentation of these documents).

Coaching during inspection

Preparation of field visits, mental preparation of participants, preparation of discussions in the inspection room, organization of the inspection and preparation of documentation.

Deviation response management

In accordance with specific references to regulatory texts :

Drafting of an action plan approved by the client
Remote and/or on-site implementation monitoring

Our know-how

We are committed to helping you achieve the state of the art in your drug manufacturing processes by:

Carrying out one or more audits and helping you define and implement an action plan
Short-, medium- and long-term monitoring of your action plans
Contributing our technical knowledge of cutting-edge technologies
Analyzing and interpreting regulatory texts in detail
Training your production and QC managers and teams in the most critical subjects (e.g. aseptic simulation processes (APS) or cleaning, disinfection and bio-decontamination activities)

Élodie PASTRE and Pierre DEVAUX
THERAXEL managers

Who we are

AUNERIPHARM, a company incorporated under Belgian law, was created as a result of the collaboration of Laurent MERLI with the directors of THERAXEL in order to offer a service to prepare you for inspections by regulatory bodies all around the world.

To achieve its objectives, AUNERIPHARM also benefits from the support of experts from :

THERAXEL, which are involved throughout the life cycle of a medicine or health product to ensure chemical, biological and microbiological contamination is controlled at every stage of the manufacturing chain

ISOTEC’XEL who provide you with their expertise in the control of barrier technologies (RABS or isolators) and in the revamping of your conventional lines.

COETIC who ensure the integrity of your data, support your digitalization projects and their compliance with US FDA and EU cGMPs.

Manager Auneripharm

After a master’s degree in chemistry at the University of Liège (Belgium), with a thesis in the Department of Organic Chemistry, I obtained a doctorate in Chemical Sciences with a thesis carried out in the Department of Radiochemistry (analytical studies of radioactive elements).

With over 25 years’ experience in the pharmaceutical industry, including 15 years in consultancy, I have had the opportunity to gain a wide range of experience. I can therefore offer you my expertise in the following areas:

Pharmaceutical, biopharmaceutical and radiopharmaceutical industries
Sterile forms, injectable or not, prepared aseptically or by terminal sterilization
Solid forms
Insurance and sterility qualification and validation activities
Project management
Process improvement
Quality assurance and control
Training and coaching

Laurent MERLI
Expert in Sterility Assurance and Nuclear Medicine