Additional Services

Beyond conventional testing, we offer supplementary analytical services that play a crucial role in pharmaceutical product development and quality assurance. Our comprehensive support in these areas ensures regulatory compliance, process stability, and product safety.

Analytical Support for Process Validations

Process validation is an essential component of GMP requirements. Our analytical tests provide reliable data for monitoring and confirming that production processes consistently deliver the desired product quality. We support you with:

• Method Development and Validation
• In-Process Controls
• Finished Product Analyses according to ICH and Pharmacopoeias (EP, USP, BP)

Cleaning Validation and Stability Studies

Our laboratories conduct comprehensive analytical tests for cleaning validation – including residue analysis of cleaning agents, APIs, and excipients.
Additionally, we provide analytical support for stability studies conducted in accordance with ICH guidelines. These include:

• Long-term and Accelerated Stability Studies
• Stress/Degradation Studies for the Determination of Degradation Products
• Analysis under Various Climatic Conditions (Zone I–IV)

Compatibility and Stress Studies

Material compatibility is a critical factor for pharmaceutical formulations. We conduct verified compatibility studies to investigate the behavior of active substances with excipients, packaging materials, or devices.
Furthermore, we perform stress studies to evaluate product stability under extreme conditions (temperature, humidity, light) – essential for reliable shelf-life prediction.

Our Process

Our additional analytical services are provided in accordance with international standards (ICH, EMA, FDA) and include:

• Analytical support for process validations
• Analytical support for cleaning validations
• Analytical support for stability studies
• Viability studies
• Stress studies

With our interdisciplinary team of experts, we support you from the development phase to market launch with robust analytical solutions.