DuSart 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

Biocartis is an innovative commercial stage molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Our proprietary MDx Idylla™ platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. Idylla™ addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.

Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest and largest growing segments of the US$6.5 billion molecular diagnostics market. Biocartis employs over 500 people and is headquartered in Mechelen, Belgium. Further information? Visit www.biocartis.com

Italian multinational company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio mainly based on hyaluronic acid (HA) in joint care, advanced wound care, ophthalmology, aesthetic and autologous biological therapy. Over 55 years of R&D have placed Fidia at the forefront in the production of natural and functionalized HA, with different ranges of MW (1,100 patents). Manufacturing operations – located in Italy - are inspected and approved by major international health authorities, including the US and Korean FDA, the Brazilian ANVISA and G-MED Notified Body, and comply with the strictest international regulations and safety standards. Fidia extends its global reach through local partners in 100+ countries worldwide, as well as wholly-owned subsidiaries in USA, Germany, Austria, Spain, France, Russia, Czech Republic, Slovakia, Romania, Egypt and Middle East.

DRUG DELIVERY SOLUTIONS - DRUG PRODUCT DEVELOPMENT - LICENSING-OUT OPPORTUNITIES

Galenix provides a range of full R&D pharmaceutical services and Drug Delivery Solutions to health companies for fast access of their products on the market.

●●● From the sourcing of the API through the Drug Product development process, including preformulation, formulation, to clinical supplies, quality control, ICH stabilities and regulatory dossier submission for Europe and US FDA registration.

Galenix provides its customers drug products “ready to launch” holding a Marketing Authorization.

●●● Galenix Innovations includes 6 different innovative technology platforms focusing on drug delivery solutions for life cycle management, new chemical entities and Biologicals using conventional medicinal presentations or its own patented technologies.

« Patients are central to our approaches »

Galenix team is focusing to preserve and/or to increase market shares on products through differentiation in accordance with regulations.

Our injectable and solid form products are manufactured in the Madrid metropolitan area in Spain. These CMO (or Contract Manufacturing Organizations) facilities are owned by ROVI Pharma Industrial Services®, a specialized Spanish pharmaceutical company, fully dedicated to research, development, manufacture and marketing of small molecules and biologicals.

In 2012, ROVI’s injectable plants received FDA approval.

From project development to product release, as well as pilot and industrial batches, ROVI® brings all of these services into a single company, allowing our clients to save considerable time and money as a result.