Comprehensive stability studies are performed on active substances and finished dosage forms under GMP conditions and in accordance with ICH guidelines. Each year, approximately 100 new stability studies are initiated.
Services include:
Available stability conditions:
Testing of highly potent substances is carried out in a dedicated 500 m² Highly Potent Substance Laboratory. The facility includes multiple laboratory spaces, a hygienic zone, and is fully autonomous in terms of personnel and equipment.
The laboratory can operate independently from other projects, with strict safety measures in place.
Validation of the manufacturing process is an essential requirement under GMP to ensure consistent product quality. This stage often generates large numbers of samples that must be analysed using approved and validated analytical methods.
Our laboratories provide capacity and expertise to support process validation when internal resources are limited. Testing covers both in-process and final product samples, as well as cleaning validation samples such as air filters, rinsing solutions, and surface swabs.
Analyses are performed using advanced instrumentation, including HPLC and LC/MS systems, ensuring accurate results and compliance with regulatory requirements.
In-vitro testing is an important tool for assessing drug bioequivalence, either as a complement to or replacement for in-vivo pharmacokinetic (PK) studies. Conscio offers dissolution systems (Apparatus I, II, IV) for both standard in-vitro testing and in-vitro/in-vivo correlation (IVIVC) studies. Capabilities also include experiments using Franz diffusion cells for in-vitro permeation testing (IVPT) and in-vitro release testing (IVRT) of topical formulations.
Correct packaging and labelling are critical for any clinical study, regardless of its phase, size, dosage form, or design. Conscio provides GMP-certified services for both primary and secondary packaging of hard and soft shell capsules and tablets.
All activities are performed in a climate-controlled environment to ensure the safe handling of even temperature-sensitive products. Services range from translations and regulatory approvals to filling bottles, blistering, and applying single, multi-panel, or digital labels.
For the validation and routine testing of analytical methods, the Pharmaceutical Analyses Department uses a wide range of modern instrumentation operated under full GMP conditions. Capabilities include:
For a complete list of instruments and methods, please contact us.
Let’s talk. Whether you’re scaling operations or prepping for your next audit, we’ll help you take the next confident step.
