qsol.dk qsol.dk

qsol.dk

Qsol Quality solutions biotech and pharma industry consultancy

Qsol offer affordable documentation systems to bio Tech and Life Sicence. Qsol offer also laboratory related tasks such as validation and stability. Have regulatory expirience from the Danish Medicines Agency

http://www.qsol.dk/

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Qsol Quality solutions biotech and pharma industry consultancy | qsol.dk Reviews

https://qsol.dk

Qsol offer affordable documentation systems to bio Tech and Life Sicence. Qsol offer also laboratory related tasks such as validation and stability. Have regulatory expirience from the Danish Medicines Agency

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qsol.dk qsol.dk
1

Qsol consultant biotech biotek quality pharma

http://www.qsol.dk/Specifications.html

At which stage of a project life cycle does your company write a specification? It is the experience of Qsol that specifications should be written in the very start of a project. The exercise of making a specification helps you to focus on the important parameters as a check list. A preliminary specification with broad or no limits can always be amended along the way. Qsol helps you setting a specification suitable for the stage of the project and a plan on how to proceed.

2

Qsol consultant biotech biotek quality pharma

http://www.qsol.dk/About-the-Company.html

Qsol offers a variety of services mainly aimed at small to medium size Biotech and pharmaceutical companies. When a university start-up company is ready to transform from a spin off to a commercially based Biotech company, the documentation needs to be streamlined before it can be used a part of a due diligence or an exit strategy. This is where the expertise of Qsol may be helpful.

3

Qsol consultant biotech biotek quality pharma

http://www.qsol.dk/Education.html

If your company is highly specialized you might have the need for training when it comes to the regulatory side of a pharmaceutical company. How to make an analytical strategy when you expect to have a partner before the project moves into a phase where validation becomes a regulatory obligation? When to set up how much stability? Is it too early to think about a specification?

4

Qsol consultant biotech biotek quality pharma

http://www.qsol.dk/Network.html

It is the strategy of Qsol to have an active network in order to offer our customers as many services as possible. Qsol has skilled and reliable contacts in the following areas:. Translation (English, Danish, and the scandinavian languages). A CRO, having a 39 authorization from the Danish Medicines Agency, performing GLP studies and bio assays. A CRO, having a 39 authorization from the Danish Medicines Agency, performing most relevant chemical testing including monographs on API and exipients.

5

Qsol consultant biotech biotek quality pharma

http://www.qsol.dk/Stability.html

Stability is one the most important parts of the formulation work. In order to be prepared for the phase one study supportive stability data is invaluable. To use discovery formulations in stability argumentation takes planning and your company should have a stability strategy in place at a very early stage of a project life cycle. Qsol can help you making this strategy and set up protocols in compliance with EU and FDA regulations.

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