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How to introduce a PV system. Electronic Application Froms (eAF). QPPV and PSMFL notifications. RA - PV collaboration. Generatorvej 8C, 1.tv. DK-2860 Søborg DENMARK Tel.: 45 3940 4860 Fax.: 45 3940 4861 Email:. Sign up for our Newsletter.

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How to introduce a PV system. Electronic Application Froms (eAF). QPPV and PSMFL notifications. RA - PV collaboration. Generatorvej 8C, 1.tv. DK-2860 Søborg DENMARK Tel.: 45 3940 4860 Fax.: 45 3940 4861 Email:. Sign up for our Newsletter.
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How to introduce a PV system. Electronic Application Froms (eAF). QPPV and PSMFL notifications. RA - PV collaboration. Generatorvej 8C, 1.tv. DK-2860 Søborg DENMARK Tel.: 45 3940 4860 Fax.: 45 3940 4861 Email:. Sign up for our Newsletter.

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1

Cases

http://www.pharmadvice.dk/cases/index.html

Standard Operation Procedures (SOPs). In 2014, a Danish subsidiary of an international pharmaceutical company approached PharmAdvice. The subsidiary needed assistance preparing new Standard Operating Procedures (SOPs) and updating the company’s current SOPs. In addition to this, PharmAdvice prepared a company template to be used for current and future SOPs. All SOPs were ready in due time for the subsidiary to be successfully inspected by the Danish Health and Medicines Authority.

2

Other Services

http://www.pharmadvice.dk/services/other-services.html

Preparing for Clinical studies is time consuming and highly regulated by authorities. Pharmadvice can assist with preparation and review of Investigator's brochure, IMPD and reference safety information as well as submission of applications to EUDRACT. Translation of Informed Consent documents. Clinical summaries and overviews. Preparation and review of:. Submission of applications - EUDRACT. What is Regulatory Affairs? New legislation and rules.

3

Troubleshooters

http://www.pharmadvice.dk/about/troubleshooters.html

Phone: 45 3940 4860. Mrs Fehrn-Christensen has more than 35 years of experience from the pharmaceutical industry with international regulatory affairs management. Partner, Regulatory Affairs and QA Manager. Phone: 45 3940 4860. More than 15 years of experience from international pharmaceutical industry, QA, and regulatory affairs with special focus on biological medicinal products, vaccines and IMPD. Certified as Qualified Person (QP). MSc Pharm., B.Com. Phone: 45 3940 4860. Phone: 45 3940 4860. PharmAdv...

4

Services

http://www.pharmadvice.dk/services/index.html

At Pharmadvice, we provide services within Regulatory Affairs, PharmacoVigilance, Quality Assurance, Marketing Support, Clinical studies and education. Whether your need is in-house assistance or a substitute for a Regulatory Affairs Manager, Qualified Person (QP) or Pharmacovigilance Manager, we can assist you. PharmAdvice also offers services within Quality Assurance and we can act as Qualified Person (QP).

5

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How to introduce a PV system. Electronic Application Froms (eAF). QPPV and PSMFL notifications. RA - PV collaboration. Generatorvej 8C, 1.tv. DK-2860 Søborg DENMARK Tel.: 45 3940 4860 Fax.: 45 3940 4861 Email:. Sign up for our Newsletter.

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