Contract Analytics

As a GMP-certified and FDA-registered contract laboratory, we offer a broad spectrum of analytical services in accordance with pharmaceutical standards.
Our service portfolio includes a wide range of methods for the testing of solid and liquid pharmaceuticals according to Ph. Eur. and USP-NF, as well as the development and validation of analytical methods for release testing and stability studies.

Current Focus: Generic Methods

What does commissioning the establishment of a generic method under GMP mean?

Generic methods are internally validated methods designed for a broad range of analytes and can be extended to your specific analyte. This means the generic method has already been fully validated according to ICH guidelines (see ICH.org – Validation of Analytical Procedures Q2 (R1)). This basic validation is supplemented by analyte-specific parameters (e.g., sample solution stability). Thus, a supplementary validation is performed for your analyte without modifying the core measurement method. As a result, your establishment costs for a GMP-compliant analysis are significantly reduced.

♦ Nitrite determination (Griess test) using HPLC (range: ppb)

♦ Residual solvent determination according to ICH Q3C

♦ Diethylene, propyl and ethylene glycol Determination

Excerpt from Our Service Portfolio

Support for formulation screening and compatibility testing during product development
Design and execution of stability studies
Development or optimization of analytical methods and transfer into the regulatory environment
Provision of QP services (internal Qualified Person for veterinary drug products and external QP for human drug products via partner network)

Method Establishment and Transfer

Preliminary investigations in accordance with Good Scientific Practice (GSP)
Method transfer under GMP conditions (including on-site training if required)
Preparation of all relevant GMP documents and SOPs

Method Development and Validation

Complete execution of method development, including definition of instrument configuration and method parameters
Validation of analytical methods, including full documentation
Revalidation of methods following changes to method parameters
Optimization of methods (e.g., duration, robustness)
Transfer of legacy methods to new equipment (life cycle management)
Troubleshooting
Creation of test specifications and SOPs

Cleaning Validation

Dissolution Studies

Solubility testing (pH profiles, solvents, modifiers, surfactants)
Preparation and planning of method transfer
Determination of dissolution behavior for quality control and stability studies under GMP (including CoA or result report)
Execution of profile dissolution in various media / pH values (f1/f2 test)
Bioequivalence testing via dissolution of originator vs. comparator (including SUPAC studies)
Biopharmaceutical characterization (profile comparison of originator vs. generic)
Adjustment or extension of relevant device parameters (temperature, volume, rotation speed, etc.)
Provision of qualification concepts and performance of qualification
Special dissolution testing: gastric resistance, buffer transitions, enzyme addition, intrinsic dissolution, simulation media, influence of food, alcohol, stress conditions, etc.

Controlled Substances

A list of our available analytical methods can be found under GMP analytics:

Learn more about GMP Analytics