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nipcos.ch

NIPCOS CONSULTING

your Consultant for Regulatory Affairs, GMP, GDP, GCP, GLP, Product Development, Quality Management, Übernahme der Fachtechnischen Leitung

http://www.nipcos.ch/

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PAGE TITLE
NIPCOS CONSULTING | nipcos.ch Reviews
<META>
DESCRIPTION
your Consultant for Regulatory Affairs, GMP, GDP, GCP, GLP, Product Development, Quality Management, Übernahme der Fachtechnischen Leitung
<META>
KEYWORDS
1 Fachtechnischer Leiter
2 Fachtechnische Leitung
3 fachtechnisch verantwortliche Person
4 Responsable technique
5 Responsabile tecnico
6 personne responsable
7 Qualified Person
8 Consulting
9 Regulatory Affairs
10 Registrierung
CONTENT
Page content here
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regulatory affairs,product development,nipcos gmbh,switzerland 9053 teufen,gmp@nipcos ch,wwwnipcos ch
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NIPCOS CONSULTING | nipcos.ch Reviews

https://nipcos.ch

your Consultant for Regulatory Affairs, GMP, GDP, GCP, GLP, Product Development, Quality Management, Übernahme der Fachtechnischen Leitung

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nipcos.ch nipcos.ch
1

NIPCOS CONSULTING

http://www.nipcos.ch/5357.html

GMP / GDP / GLP/ GCP / Quality Management. Provisioning of your Qualified Person / Technical Responsible. Taking over the technical responsibilities of the company. Negotiations and correspondence with the authorities. Company, wholesale, manufacture and/or narcotic licences). Preparation, establishment, update and care of your QA system. GMP / GDP / GLP/ GCP). Batch release and shipment release. Preparation and pass you through authority inspections. Carrying out of internal and external audits.

2

NIPCOS CONSULTING

http://www.nipcos.ch/5294.html

Consultancy to receive and maintain marketing authorisations and. Management of your regulatory projects. Bull; Advice on registration strategy (data review and assessment of feasibility). Bull; Preparation and submission of Marketing Authorisation Applications,. Drug Master Files and all types of registration documentation. NDA, ANDA, CTA, CTD, variation). Bull; Negotiation with the authorities through the approval process. Preparation of responses and meetings).

3

NIPCOS CONSULTING

http://www.nipcos.ch/5378.html

Nous assumons, dans le cadre d‘un mandat, la responsabilité technique de votre entreprise vis-à-vis de Swissmedic, par exemple pour le commerce de médicaments en Suisse ou à l’étranger ou pour la fabrication de médicaments. Selon votre besoin nous pouvons assurer dans le cadre du mandat soit la totalité des tâches pharmaceutiques, comme par exemple l’assurance de la qualité, la pharmacovigilance soit des tâches partielles isolées :. Négociations and Correspondance avec les autorités.

4

NIPCOS CONSULTING

http://www.nipcos.ch/5252.html

Verhandlungen & Korrespondenz mit den Behörden. Aufbau, Aktualisierung und Betreuung Ihres QS - Systems. GMP / GDP / GLP/ GCP). Vorbereitung und Durchführung der Behördeninspektionen. Durchführung interner und externer Audits. QS Projekte and QS Aufgaben aller Art. Betreuung Ihrer Lieferanten / Hersteller / Lohnhersteller / Logistik. Aufbau, Aktualisierung und Betreuung Ihrer Produkt Dossiers. Gerne arbeiten wir Ihnen ein Angebot zur Prüfung aus!

5

NIPCOS CONSULTING

http://www.nipcos.ch/5315.html

More than 20 years of experience with very impressive results. High level of authority acceptance (e.g. Swissmedic, FDA). Worldwide experience with proven results (e.g. FDA and EMEA). Highly rationalized and professional solutions and operations. Tailored solutions integrated into your system. Competent partner for all stakeholders. Their regulatory affairs work in drug development or quality projects. Our GMP consultants lead authority inspections such as FDA pre-approval inspections or Swiss authority ...

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Fachtechnischer Leiter, Fachtechnische Leitung, fachtechnisch verantwortliche Person, Responsable technique, Responsabile tecnico, personne responsable, Qualified Person, Regulatory Affairs Consulting, Registrierung Consulting, Zulassung Consulting, GMP Consulting , GDP Consulting, GCP Consulting, GLP Consulting, Behördeninspektion, authority inspection, quality management Consulting, audit, Pharmacovigilanz, pharmacovigilance, quality assurance, Qualitätssicherung, Swissmedic. Our experts consult you in.

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