Phases
Developing a new drug is a complex journey, with scientific, clinical, and regulatory challenges at every stage. As a leading CRO, we deliver reliable analytical solutions that ensure safety and efficacy—helping biotech and pharma companies move forward faster and with confidence. From early research to market launch, our expertise supports every phase of your molecule’s life cycle.
Early phase - laying the groundwork for compliance
Even at the earliest stages, analytical foresight is key. Applying rigor from the start ensures a smooth and compliant development pathway. We lay the foundation for your success by offering:
- Custom method development aligned with ICH guidelines
- A GLP/GMP-compliant environment to ensure future method validation without complications
This proactive approach generates reliable data for your preclinical dossiers, which are essential for evaluating the safety and efficacy of your molecule.
Preclinical phase - generating reliable data for your preclinical dossier
In the preclinical phase, the goal is to generate reliable data for your dossier. We deliver analytical services that support safety and efficacy evaluation under GLP certification, including:
- Assay of active drug substance
- Pharmacokinetic and toxicokinetic (PK/TK) tests
- Biomarker analysis
- Immunogenicity assessment
- In-use stability tests
- Drug interaction tests
Beyond GLP bioanalysis, Quality Assistance partners with you on the CMC aspects of drug development. We help secure the success of your programme by developing robust analytical methods for intermediates, drug substance (DS) and drug product (DP), conducting preliminary stability studies, supporting formulation development, and providing in-depth product characterisation as well as analysis of toxicology batches. Our integrated expertise ensures you generate reliable data early on, de-risking your development path.
Clinical phase (I, II, III) - generating robust, inspection-ready data for accelerated clinical development
Clinical trials are the heart of drug development, where every data point matters. Our expertise ensures the robustness and traceability of your data for a smooth inspection process by regulatory authorities (EMA, FDA).
We support you with our CMC and Bioanalytical services, all conducted under GMP or GLP certification.
CMC Services (GMP-certified)
- Development, validation, and implementation of analytical methods for quality control and characterisation studies.
- In-process control (IPC) testing.
- Comprehensive analytical support for CMC dossiers, preparing the ground for regulatory approval.
- Stability studies to determine shelf life and storage conditions.
Bioanalytical Services (GLP-certified)
- Pharmacokinetic (PK) and toxicokinetic (TK) studies to understand the drug's fate in the body.
- Biomarker analysis to assess therapeutic effects and safety.
- Immunogenicity assessment to detect potential adverse immune reactions.
We also offer flexible support for adaptive protocols and provide the necessary documentation.
Our services
Marketing authorisation and commercialisation - ensuring quality and compliance from launch to lifecycle management
Market authorisation is not the end: it is the beginning of an ongoing commitment to quality and compliance. We ensure the longevity of your product by providing continuous analytical support, from launch to lifecycle management.
Our services include:
- Method optimisation and validation for commercial production
- Analysis of pilot and Process Performance Qualification (PPQ) batches
- Preparation of Certificates of Analysis (CoA)
- Long-term and ongoing stability studies
- Analytical support for Marketing Authorisation Application (MAA) submissions
- Commercial batch testing and result release
All our services are GMP-certified, with statistical support for all analytical data, guaranteeing the quality of your product throughout its market life.
Discover our products
When the path isn't clear, our custom solutions guide you forward
The development of innovative medicines is a journey driven by the hope of bringing relief to those in need. Our role is simple: to provide the analytical clarity and confidence you need to simplify the path.
Our expertise, precision and unwavering commitment to quality are our way of helping you deliver on that promise. We ensure that every drug that reaches a patient is safe, effective and of the highest quality, transforming your scientific rigor into real-world patient outcomes.
To learn more about our approach and services, contact our experts today.