EirGen Pharma

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of:
- Biologics (monoclonal antibodies, ADCs, proteins)
- New Chemical Entities, oligonucleotides, peptides
- Nanomedicine products
- Vaccines
- Cell-Based and Gene Therapy Medicinal Products

The company holds a unique position on the market with:
All its laboratories on one site (Donstiennes, Belgium)
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.

Our core competencies are:
QUALITY (CMC)
- Development and validation of analytical methods
- Characterisation
- Stability studies
- Batch (release) testing
SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit www.quality-assistance.com for more information

CEVEC is a leading provider of high-performance cell technology for the manufacturing of advanced bio-therapeutics from R&D to manufacturing scale. The company’s product portfolio comprises platform technologies for gene therapy viral vectors, vaccines and complex recombinant proteins.

With the ELEVECTA® Technology, CEVEC offers a unique solution for large-scale production of AAV vectors using helper virus-free producer cell lines with all necessary components stably integrated into the cell. The technology is based on suspension cells and does not require any expensive transfection reagents and cGMP plasmids.

CEVEC’s CAP® Technology based on human suspension cells is the ideal production platform for RCA-free Adenoviral vectors, Lentiviral vectors, viral vaccines and exosomes.

With the CAP-Go® Technology CEVEC provides a solution to the increasing need for recombinant production of complex and highly glycosylated protein molecules, including laminins, coagulation factors and plasma proteins.

Porton Biopharma Limited (PBL) is a UK based company experienced in developing and manufacturing biopharmaceutical therapeutics and vaccines.

PBL was corporatised out of Public Health England on 1st April 2015 to enable us to be better placed to grow our business, which is built upon decades of biopharmaceutical experience including the successful commercialisation and licensure of many therapies which now save thousands of lives every year, and generate revenues from world-wide sales.

Our strategy as an evolving company with a distinguished heritage is to grow and develop our existing business and products, whilst also building relationships across the industry.

As a growing company we are always looking to recruit talented individuals at all levels who have the drive and enthusiasm to help us get to where we want to be, and who are proud to be part of a team producing life-saving products that really make a difference.

Visit our website to find out more and see a complete list of our latest vacancies.

PharSafer® is a niche CRO and Pharmacovigilance & Medical Services specialist.

PharSafer® provides tailored solutions to act as a complete Pharmacovigilance, Cosmetovigilance and Medical Services department. PharSafer® is able to perform all of the activities expected of in-house Pharmacovigilance and Medical Information departments in order to be compliant with the necessary legislation, providing quality information to healthcare professionals and patients, and ensuring that the company achieves a high performance service at the point at which it's needed.

PharSafer® was founded in 2002 and has continued to celebrate year on year growth and subsequent expansion since. Headquartered in the United Kingdom, PharSafer® is a privately-owned company and has offices in both the UK and Middle East, and has additional plans for offices around the world. Clients range from major pharmaceutical companies through to niche biotechnology companies and span across 7 continents. PharSafer®, in conjunction with its sister company SaPhar, is one of the most effective training organisations in the Pharmacovigilance and Medical Services field for drug companies, including medical devices and vaccines.

PharSafer are always looking to add talented Pharmacovigilance & Medical Information Professionals, Physicians, Quality Assurance Associates, Pharmacovigilance Administration personnel and IT Computer Programmers to the team. If you are interested in joining us, take a look at the PharSafer website for a list of current vacancies - http://www.pharsafer.com/about-us/work-with-us/

Altogether, we are PharSafer.

There are several GLP-compliant non-clinical CRO’s. Why choose the Aurigon Group?
• We're big enough to provide a full service, but small enough to fully adapt to your needs
• Our qualified staff consists of 70+ professionals, with even 30+ years of experience
• Our proven track record of more than 5700 studies gives us a solid base to serve your needs
• Our flexible approach and your direct contact to the Study Director gives you full control of your study

Aurigon offers a full range of in vivo and in vitro non-clinical services from development candidate to marketed product. These services include, but are not limited to: PK/PD, ADME, bioanalytics, toxicology and safety pharmacology in all species used in toxicity testing ranging from mouse to minipig.

For our clients we provide tailor-made services on a variety of test item classes including NCE, NBE, herbal extracts, vaccines, medical devices to name a few. We intend to build up long-term partnerships by acting as a problem-solver in our partners’ projects; keeping their budget, timeline and goals in mind.

Aurigon shares its expert knowledge and performs GxP training services (GLP, GMP for batch release assays, GcLP). Our clients will benefit from our comprehensive experience and get new insight into the GxP regulated environment.

As Central European Center for Minipig Research we possess a spacious site as well as sound professional experience for minipig testing. This is accompanied by facilities for small and large animal testing (rodents, rabbits, dogs, ...) as well as in vitro laboratories close to the city borders of Budapest. Furthermore, we maintain a well-equipped bioanalytical department in Budapest.

For more detailed information about our broad service portfolio you may also visit our website (www.aurigon.eu).

Get in touch and let us foster your project a wing stroke ahead!

Studies are performed by our sister company, ATRC Aurigon Toxicological Research Center Ltd.