GMP Contract Analytical Services
Contract Analytical Services: GMP Excellence and AIFA Authorization for Pharma and Biotech
In the highly regulated landscape of pharmaceutical development, choosing a reliable testing partner is a critical factor for ensuring the safety, compliance, and therapeutic success of new products. Diatheva stands as your ideal strategic partner, offering a comprehensive suite of Contract Analytical Services authorized by AIFA (Italian Medicines Agency) and in full compliance with GMP standards.
We specialize in actively supporting pharmaceutical and biotech companies throughout the entire lifecycle of investigational medicinal products (IMPs). Our analytical capabilities span from the delicate preclinical stages right through Clinical Phases I and II, delivering robust, traceable, and top-tier data to propel your molecules forward.
Our Core Quality Control Capabilities
Operating under strict GMP guidelines, Diatheva’s analytical scope focuses on four high-level macro-areas critical to product safety, regulatory approval, and detailed molecular characterization:
- Physicochemical Analysis: we conduct rigorous testing for structural characterization, identity verification, and purity assessment. Furthermore, we design and execute dedicated stability studies, which are essential for defining shelf-life and understanding degradation profiles under various storage conditions.
- Microbiological Testing (Excluding Sterility) we provide routine bioburden monitoring and strict hygiene quality control. These analyses are vital for both production intermediates and finished products, ensuring that the required microbiological standards are maintained throughout the manufacturing process.
- Biological Assays (Bioassays): leveraging deep scientific expertise, we specialize in the development, optimization, and validation of complex bioassays. These tests are indispensable for accurately determining the biological activity and molecular potency of innovative biologics and biotech products.
- Bacterial Endotoxins: we perform critical pyrogenicity and safety testing in strict compliance with major international pharmacopoeias (EP, USP, JP). This quality control step is non-negotiable to exclude endotoxin contamination and guarantee patient safety.
Customized development and validation of Analytical Methods
Recognizing that every molecule and project presents unique challenges, Diatheva goes beyond standardized protocols.
Our true value lies in our ability to deliver tailored solutions for the customized development and validation of analytical methods.
Whether you need to transfer an existing method, optimize an assay to improve specificity, or validate a protocol from scratch according to ICH Q2 guidelines, our team of scientists works in close collaboration with your R&D and Quality Control departments.
We ensure a seamless transition that successfully withstands regulatory scrutiny and inspections.
Why choose Diatheva as your Analytical Partner?
Partnering with Diatheva for your contract analytical needs means choosing scientific rigor, process safety, and high-level support to successfully transform your biotech research into clinical reality.
- Total Regulatory Compliance: We operate out of AIFA-authorized and GMP-certified laboratories, providing the highest assurance of data integrity and robustness for your regulatory submissions.
- Flexibility & Collaborative Approach: We view ourselves as a seamless extension of your own laboratory. We guarantee transparent communication, rapid turnaround times, and strict confidentiality management.
- Advanced Scientific Expertise: Our team possesses profound expertise in handling complex biological molecules, monoclonal antibodies, recombinant proteins, and enzymes.
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