Biotherapeutics
Biotherapeutics represent one of the most dynamic and promising segments of drug development. this category includes antibodies, antibody-drug conjugates (ADCs), proteins and recombinant peptides. These are advanced molecules at the core of today’s most innovative therapies.
These products have already transformed the treatment landscape across multiple therapeutic areas: oncology, immunology and autoimmune diseases, infectious diseases, diabetes and metabolic disorders.
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Why partner with Quality Assistance?
Choosing the right analytical partner is decisive to bring your biotherapeutic to market efficiently and in full compliance. At Quality Assistance, we offer:
- 22 years of track record: our experience, dating back to 2002, includes a proven history of successful regulatory submissions for global pharma and biotech companies.
- Capacity and focus: in 2024 alone, we managed 73 distinct biotherapeutic projects. This volume demonstrates our scientific focus and operational agility.
- Unified efficiency (Single-Site): all our GxP laboratories are located on a single site. This ensures that CMC and bioanalysis data are shared seamlessly and quickly, avoiding the delays common in multi-site management.
- Integrated GxP environment: we provide a quality continuum, from method development through GxP-compliant method validation and routine analysis. Strict adherence to EMA, FDA, and ICH guidelines is the foundation of every analytical report.
- A scientific extension of your team: we identify the specific analytical aspects of your molecule and provide concrete solutions to accelerate patients’ access to your innovative therapy.
Driving biotherapeutics development with clarity and compliance
With Quality Assistance, you gain more than an analytical CRO. You gain a strategic partner dedicated to the success of your biotherapeutic.