CMC Services
Transforming your CMC requirements into a clear, compliant path forward. As your drug candidate moves from discovery to clinical development, the Chemistry, Manufacturing and Controls (CMC) phase becomes critical. At every step of your development process, you need to demonstrate product quality and prove that it is consistently manufactured, safe and compliant with international standards.
All of the below steps must be achieved while meeting tight timelines and anticipating evolving regulatory expectations, as any CMC-related issues can significantly delay or jeopardise the initiation of clinical studies and the eventual marketing authorisation.
At this point, analytical precision and excellence is not an option. It is what keeps your development moving forward. At Quality Assistance, we know how complex this stage can be and that’s where we become your strategic partner. Our role is to support your development process with proven expertise, so you can stay focused on your innovations while we secure your analytics.
Partnering with you at every CMC milestone
Our role is to make your CMC journey smoother, faster and fully compliant. We work as an analytical extension of your teams, aligning with your strategy and developing tailored solutions adapted to your molecule and development stage.
Our experts help you anticipate your upcoming challenges, propose solutions that match your timelines and deliver compliant data packages ready for regulatory submission. With all capabilities integrated under one roof, you benefit from faster coordination, stronger data integrity and complete visibility across every analytical phase.
Our CMC support covers
- Analytical development: development, transfer and validation of analytical methods that define your product’s quality in full compliance with EMA, FDA and ICH standards, in a phase appropriate manner.
- Batch testing: confirmation that each batch meets your specifications for clinical and commercial release
- Stability studies: generation of data that characterise your product’s behaviour over time, define its shelf-life and ensure its long-term performance
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Why innovators trust us
Every company has different needs. Whether you’re a biotech accelerating your first clinical trial submission or a pharma scaling a global programme, you need an analytical partner who can combine scientific depth with operational agility.
By working with Quality Assistance, you benefit from the strengths that serve your goals:
- 40+ years of analytical expertise focused on innovative medicines
- A single-site model ensuring efficiency and consistency
- Dual EMA and FDA regulatory insight
- A team of analytical experts working under a unified GxP framework
- Continuous investment in R&D (10–15% of turnover) to stay ahead of emerging technologies
- A 94% client retention rate proving our client’s satisfaction
- A complete set of analytical techniques and technologies to respond to all your analytical challenges
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Let’s make progress together
Let’s shape your analytical strategy together with precision, reliability and the shared goal of delivering life-changing therapies to patients sooner.
Contact our experts to discuss how we can support your analytical development, batch release and stability studies.