New chemical entities
At Quality Assistance, we know that New Chemical Entities (NCEs), including oligonucleotides, synthetic peptides and synthetic small molecules, are central to today’s pharmaceutical drug development programmes.
Investigated for the treatment of a broad array of conditions, including pain, infections, cardiovascular and neurological disorders, cancer, genetic diseases and immune-related pathologies, these targeted modalities demand exceptional analytical precision.
Each New Chemical Entity (NCE) is investigated for its potential to address unmet medical needs through a defined mechanism of action, aiming to improve therapeutic efficacy and specificity.
Yet, transforming a promising molecule into a safe and approved medicine requires more than innovation: it demands robust analytical expertise, regulatory compliance and a trusted partner to navigate a highly complex development pathway.
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Your partner for NCE development
For over 43 years, we have been dedicated to supporting the pharmaceutical industry in bringing New Chemical Entities to market. Our experience spans projects with agile biotech companies as well as global pharmaceutical leaders, giving us a unique understanding of the diverse challenges across the industry. In 2024 alone, customers trusted our expertise for 45 NCE development projects.
By partnering with Quality Assistance, you gain:
- Accelerated timelines: all laboratories on a single site, ensuring seamless coordination and faster data delivery for critical decision-making.
- Validated GxP framework: end-to-end GxP coverage, fully aligned with EMA, FDA, and ICH requirements, providing an undeniable foundation for your submissions.
- Tailored scientific strategy: custom-designed analytical plans, precisely matched to the unique characteristics of your molecule, no generic or one-size-fits-all approach.
- Confidence and certainty: work with a dedicated scientific partner whose sole commitment is the success and validity of every stage of your development.
Driving your NCE development with confidence
Our role goes beyond providing data. We stand beside you as a partner, anticipating challenges, adapting to your needs and ensuring that your molecule advances with both speed and scientific integrity. Together, we aim to achieve the same goal: helping patients gain access to safe, innovative medicines.
Speak with an analytical expert