Compliance
Services

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Our compliance services ensure that your company fulfils all relevant laws, regulations, standards and ethical principles of the pharmaceutical industry in the best possible way. Our technical support team will be happy to answer any questions you may have on this topic and provide you with advice and assistance. Being the producer, we are the ones who know our devices the best. Fast diagnosis and effective maintenance are thus guaranteed.

Installation

Installation

Direct device installation and configuration on your property is done by our knowledgeable experts. The installation not only ensures that the hardware is ready for operation, but also that the device software is installed and integrated into your LIM system.

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Installation qualification (IQ)

Installation qualification (IQ)

We will provide written support for your SOTAX device installation upon request. We meet all requirements set forth by the most recent pharmacopoeias, including the USP, the PPRC and the European Pharmacopoeia.

 

An assessment of your API's solubility in one or more aqueous mediums that replicate physiological settings and meet sink requirements.

Dissolution, Performance Verification Testing (PVT)

Dissolution, PVT

 Performance Verification Testing (PVT) is a holistic test performed by our highly qualified employees using the reference standard material and procedure. This allows the results of your instrument to be compared with those of other laboratories worldwide.

 

IVRT investigations for intricate formulations like liposomes, injectables, or ocular solutions that rely on a revolutionary in-vitro methodology.

Re-qualification Services

Re-qualification Services

Periodically, our experts will come see you to re-qualify your devices. All current pharmacopoeia requirements are met by this qualification.

 

IVRT investigations for intricate formulations like liposomes, injectables, or ocular solutions that rely on a revolutionary in-vitro methodology.

Operational qualification (OQ)

Operational qualification (OQ)

Our technical support team can characterise the process, determine the process window, and pinpoint the crucial production parameters during operational qualification.

 

IVRT investigations for intricate formulations like liposomes, injectables, or ocular solutions that rely on a revolutionary in-vitro methodology.

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