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SVINX-CONSULTANCY.NL

Svinx Consultancy - Pharmaceutical support

Svinx Consultancy offers among others QA and QP support. Next to that also pharmaceutical support, like formulation and analytical development are offered

http://www.svinx-consultancy.nl/

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Svinx Consultancy - Pharmaceutical support | svinx-consultancy.nl Reviews

https://svinx-consultancy.nl

Svinx Consultancy offers among others QA and QP support. Next to that also pharmaceutical support, like formulation and analytical development are offered

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1

Services - Svinx Consultancy

http://www.svinx-consultancy.nl/services

Svinx Consultancy can offer the following services for your company. More details per service can be found by clicking on the link. If you feel that there is anything else that I can help you with, contact me and we can discuss your needs. RT @Roche: Did you know that on average it takes t. Jan 9, 2017. RT @Roche: Antibodies are Y-shaped proteins produc. Dec 11, 2016. Geweldig stuk over vaccineren! Oct 26, 2016.

2

Pharmaceutical Development - Svinx Consultancy

http://www.svinx-consultancy.nl/services/pharmaceutical-development

Once a lead candidate has been selected for further clinical development, i.e. when the desired activity and safety of the active pharmaceutical ingredient ( API. Has been proven in animal models, the clinical development of the product needs to be started. This usually starts with formulation development. Furthermore the stability of the chosen formulation needs to be proven during a suitable stability program. RT @Roche: Did you know that on average it takes t. Jan 9, 2017. Dec 11, 2016. Oct 26, 2016.

3

Qualified Person - Svinx Consultancy

http://www.svinx-consultancy.nl/services/qualified-person

According to European Legislations ( Annex 16. To Eudralex – Volume 4 Good manufacturing practice (GMP) Guidelines; Directive 2001/83/EC. Produced drug products need to be released by a Qualified Person. QP) The QP is solely responsible for the quality and safety of the released products. The QP needs to be independent of the production department. Furthermore he/she needs to be acknowledged as QP by the Dutch authorities (IGZ). 2 thoughts on “ Qualified Person. Pingback: Wat betekent QP? Jan 9, 2017.

4

Links - Svinx Consultancy

http://www.svinx-consultancy.nl/links

8211; Eudralex – Volume 4 Good manufacturing practice (GMP) guidelines. 8211; Directive 2001/83/EC of the European Parliament and of the Council. 8211; Directive 2001/20/EC of the European Parliament and of the Council. 8211; International Conference on Harmonisation. 8211; European Medicines Agency. 8211; US Food and Drug Administration (FDA). 8211; Good distribution practices. RT @Roche: Did you know that on average it takes t. Jan 9, 2017. RT @Roche: Antibodies are Y-shaped proteins produc.

5

Quality Assurance - Svinx Consultancy

http://www.svinx-consultancy.nl/services/quality-assurance

Setting up a quality system. If you are making or already have made the switch to production of clinical trial material, a quality system needs to be built. Setting up a quality documentation system. Part of the quality system is the documentation system. This consists of SOP. S, Site Master File, work instructions, etc. One thought on “ Quality Assurance. Pingback: Wat betekent QP? RT @Roche: Did you know that on average it takes t. Jan 9, 2017. RT @Roche: Antibodies are Y-shaped proteins produc.

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Fam. Vink-Hermeling » Suzanne

http://deefsuus.nl/suzanne

Suzanne, Deef, Andrea and Lisa. In June 2008 she started working as a QP (Qualified Person) at the same company until April 2011. In May 2011 she started working as a QI manager and Qualified Person at Hal Allergy B.V. In Leiden. In July 2014 she started to work at Prosensa Therapeutics. As a Qualified Person. Next to that she is starting up Svinx Consultancy BV. She can be followed on twitter. In maart 2013 is ze begonnen met haken. Het resultaat hiervan kan gevolgd worden op mijn haakblog.

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Svinx Consultancy - Pharmaceutical support

Welcome to the website of Svinx Consultancy. Svinx Consultancy is a company owned by Suzanne Vink-Hermeling. Svinx Consultancy offers among others QA and QP support. Next to that also pharmaceutical support, like formulation and analytical development are offered. In the section “ Personal. 8221; you can read more about my experiences in Research and Development and in GMP environments. I will keep you updated about any interesting items I come around. Phone or social media. Jan 9, 2017. Dec 11, 2016.

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