Quality Assurance
At Boletus Consulting, we understand that effective Quality Assurance is not a cost-center but a way-of-running a business.
If you want to set-up an effective way to set-up your own quality assurance system or even want to enhance you current process, we at Boletus Consulting can provide you with clear-cut procedures, real-life examples and effective training programs for your entire staff.
We can tailor-made a quality system which will meet your needs. From small start-up to larger bio-tech companies we can help you with setting-up scalable processes geared up for growth, defining the right levels of responsibility within your organization.
- Deviations & CAPA management
- Change Control flow
- Training follow-up
Regulatory Affairs
In the highly regulated environment of pharmaceuticals & biologicals, contact with the different health authorities is key.
With a proven track record of successful submissions, we, at Boletus Consulting, can help you with both defining the content & the format of your application
A sound and solid regulatory strategy is essential in bringing your pharmaceutical or bio-tech product to the market.
- Filing a (first) clinical trial application
- Preparing a scientific advice meeting with your local or European health authorities
- Compiling a full submission dossier according to the correct international standards
- Identifying & managing the risk of your application
At Boletus Consulting we can offer you a tailor made support meeting your current and future needs.
GxP Audits
One of the key elements for an effective quality system is to define the correct responsibilities and setting up a strict audit program.
All GxP audits are conducted by the Boletus consulting team are using pre-set guidelines and regulations, a systematic approach for review of the current process and an evaluation using a scoring system. The outcome of a GxP audit is a report by a certified auditor detailing the current status of the auditee and a section with suggestions for improvement. The audit reports can be used as part of the quality cascade and chain of responsibilities within the pharmaceutical GMP, GCP and GDP environment.
At Boletus Consulting we offer a wide variety of audits, audits schemes and even audits trainings for the different quality groups.
Please ask us for a quote for your next GxP audit.
About Us
Seppe de Gelas is a seasoned expert providing consulting services to the industry. His focus is on quality assurance and regulatory expertise, with a particular interest in the integrated support for both medical device and pharmaceutical companies, including active pharmaceutical ingredients (API) and final drug product services for the medical devices, pharmaceutical and tissue industries. He is a multilingual director with close to 20 years of experience in international pharmaceutical manufacturing. His professional interests include Quality Assurance, Quality Systems and Quality Control for both the medical device and pharmaceutical industries, with a focus on small and medium size enterprises.
He is a peptide chemist by education and graduated in 1994 from the Vrije Universiteit Brussels (Belgium).
He is also a lecturer European Regulatory Affairs at the Pharmacy Faculty of the University of Georgia (USA).