Pharmaceuticals & Veterinary Medicine
Analytical support during manufacture and finished product testing
Analytical Support During Manufacturing & Finished Product Testing for Pharmaceuticals & Veterinary Medicine
Outsourcing your GMP and CMC pharmaceutical laboratory services can help you to optimise and accelerate your manufacturing and commercial release programs. Whether you are looking for raw material testing, in-process control (IPC), or finished product testing CEMAS offers comprehensive analytical support throughout the manufacturing process and following product release, ensuring the highest levels of safety, efficacy, and quality for pharmaceutical and veterinary medicine products.
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Method Development and Validation
Our team has a proven track record in developing and validating analytical methods that are robust, accurate, and compliant with regulatory standards. We employ a wide array of techniques, including chromatography (HPLC, UPLC, GC), spectroscopy (UV, IR) and mass spectrometry, to meet the specific needs of your API and small molecule analysis. Our methods are designed to ensure precision, reproducibility, and suitability for routine use in both R&D and quality control environments.
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Small Molecule Assessment
Explore how CEMAS can provide full characterisation and assessment services to help understand the behaviour of your API and small molecules in your various formulations. We can help navigate the complexities of raw material sourcing, mitigate risks, quality control, ensure compliance with regulatory requirements and improve the overall quality of your products.|
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Chemical and Physical Characterisation
To guarantee consistency and quality, CEMAS offers comprehensive, GMP, chemical and physical characterisation services to ensure that your raw materials, APIs and finished products meet the required standard of quality and performance.
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Tablet and Capsule Testing Solutions
For oral dosage forms, we offer a complete tablet testing service to include: dissolution, disintegration, hardness, friability, content uniformity, dimension, weight and moisture content variation testing to comprehensively assess product manufacture against its specification.
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Cleaning Validation and Verification
CEMAS offers cleaning method validation and verification testing services to ensure the cleanliness of manufacturing equipment and facilities to prevent cross-contamination between products; ensuring maintained product integrity during production.
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Shelf-life and Stability
CEMAS designs and conducts stability studies under ICH and VICH recommended conditions to assess the degradation, shelf life, and recommended storage conditions of your raw materials and final products. We offer both real-time, long-term stability under various environmental conditions, as well as accelerated stability studies.
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Contamination and Impurity Assessment
We provide thorough impurity profiling services, including identification, quantification and control strategy development. Our state-of-the-art analytical techniques enable us to detect and characterise even trace levels of impurities, ensuring your product’s safety profile is uncompromised
Find out more about Impurities
Category | Analytical Solutions Offered |
---|---|
Method Development | Analytical Method Development Stability-Indicating Method Development Impurity profiling |
Regulatory Compliance | Validation of Analytical Methods (ICH/VICH Guidelines) Batch Release Testing Regulatory Submission Support |
Advanced Characterisation | Structural Elucidation Chromatographic Techniques Spectroscopic Analysis |
Stability Studies | Stability Testing Forced Degradation Studies Shelf-Life Determination |
Quality Control | Assay Testing Content Uniformity Dissolution Testing Residual Solvent Analysis |