Our Services – Pharmaceuticals & Veterinary Medicine
Small molecule assessment services
Small Molecule Assessment Services for the Pharmaceutical and Veterinary Medicine Industries
Ensuring Quality, Compliance, and Safety
Quality and consistency of raw materials and active pharmaceutical ingredients (APIs) is the foundation of any effective and safe of pharmaceutical and veterinary product. Rigorous assessment and quality control are essential to prevent any potential risks that could arise from contaminants, impurities, or substandard ingredients. CEMAS offers a comprehensive small molecule assessment service in GMP-compliant laboratories, designed to help you navigate the complexities of raw material sourcing, mitigate risks, quality control, ensure compliance with regulatory requirements and enhance the overall quality of your pharmaceutical products, ensuring these meet the stringent safety and efficacy criteria.
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Our Services
CEMAS is committed to helping you achieve the highest standards of quality and compliance. We are fully GMP compliant and conduct thorough evaluations to assess the quality, purity and safety of raw materials used in your manufacturing processes, with services that include:
- Assessment following pharmacopoeia monographs (USP/EP/BP/JP)
- Identification and characterisation of raw materials
- Physical property assessment
- Purity and impurity profiling, including heavy metals
- Particle characterisation
- Stability Testing of APIs under various conditions to ensure their effectiveness throughout the product’s shelf life – Find out more
- Certificate of Analysis verification, ensuring CoAs provided by suppliers are accurate and reliable
- Method development and validation
- Custom solutions – We understand that each pharmaceutical product has unique requirements and are ready to provide customised support tailored to your specific needs
| Testing Solution | Industry | Description | |
| Pharma | Vet Med | ||
| Identification & Characterisation | YES | YES | Confirming the identity and chemical structure of raw materials and APIs using techniques such as FTIR and MS. |
| Purity & Impurity Profiling | YES | YES | Analysing the purity and detecting impurities and by-products via HPLC, LC-MS, and GC-MS. |
| Polymorphism Testing* | YES | YES | Testing crystalline structures to detect polymorphic forms that may affect bioavailability and manufacturing processes. |
| Stability Testing | YES | YES | Evaluating how raw materials and APIs respond to environmental factors (temperature, humidity, light) to ensure long-term product efficacy and safety. |
| Microbial Contamination Testing* | YES | YES | Screening raw materials and APIs for harmful microbial contaminants, including bacteria, yeast, mould, and endotoxins. |
| Residual Solvent Analysis | YES | YES | Testing for residual solvents in raw materials and APIs in accordance with ICH Q3C guidelines. |
| Heavy Metals & Elemental Impurities | YES | YES | Testing for heavy metals and elemental impurities via ICP-MS to ICH Q3D guidelines. |
| Pharmacopoeial Compliance | YES | YES | Ensuring raw materials and APIs comply with global pharmacopeial standards. |
| Assay Development & Potency Testing | YES | YES | Developing custom assays to quantify API potency and ensure accurate therapeutic effects. |
| API Degradation Product Analysis | YES | YES | Identifying degradation products of APIs under stressed conditions to ensure stability and safety throughout shelf life. |
| Batch Release Testing | YES | YES | Comprehensive testing to ensure raw materials and APIs meet predefined specifications for quality control before market release. |
| Species-Specific API Testing | NO | YES | Tailored API testing to account for the unique metabolic and physiological characteristics of different animal species. |
| Environmental Impact Assessment | YES | YES | Assessing the environmental impact of APIs, particularly in veterinary applications, to meet environmental safety regulations. |
Table 1. Overview of the raw materials and API testing solutions tailored for the Pharmaceutical and Veterinary Medicine industries.
*Service currently outsourced to testing partner
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
