+49 (2821) 7277-0 kontakt@mit-gesundheit.com

Management for your products

We offer you a very wide spectrum of support services in the fields of pharmaceuticals, dietary supplements and medical devices.

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Pharma­covigilance

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Regulatory affairs

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Quality management

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New business development

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Contract management

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Assumption of responsibility

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Dietary supplements

Short-term specialists save long-term costs

Effective management and discussions about costs regularly become more intense when a company faces new challenges, especially when the overall economic situation becomes more difficult.

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Pharmacovigilance

With intelligent market strategies, you can lead your prescription preparations as well as your OTC products to success. You want to invest in the market and not build up a staff of highly qualified PV employees that you cannot utilise to capacity with PV tasks.

Worldwide literature research
Responsible persons
Signal Detection and PSURs
Clinical trials
PV Training
Readability tests
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Regulatory affairs

In the field of regulatory affairs, we offer numerous services that can be called upon on a project- or product-related basis. If required, we can support you throughout the entire product life cycle.

Implementation of approval procedures
Notifications of variation / Variations
Applications for renewal of marketing authorisations
Transformation into the eCTD format

Quality management

We structure and organise your quality management with a variety of services that serve to establish and expand your quality assurance system.

Quality assurance manual
SOPs for special tasks
Staff training
Internal audits according to AMWHV
Audits
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New business development

MIT Gesundheit GmbH supports you from the start-up of a new business to the launch of a new product. We have been creating a preparation exchange and a brand exchange for over 25 years.

Trademark exchange
Preparations exchange
Function Marketing Authorisation Holder / MAH

Contract management

On the basis of many years of experience, we help with the individual drafting of contracts and we also support you in the implementation of the contract contents in your quality management (QM) system.

Delimitation of responsibility agreements (VAV)
Safety Data Exchange Agreement (SDEA)
Individual contracts with responsible persons
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Dietary supplements

We support you in all questions concerning the marketability and safe distribution of your dietary supplements.

Product maintenance of dietary supplements
Examination of health claims on dietary supplements

Assumption of responsibility

Our specialists will then take over all the responsibilities of a marketing authorisation holder for you on a temporary basis, while you can concentrate on the successful marketing of your products.

Step-by-step plan representative according to § 63a AMG
QPPV according to "Article 104 (3)(a) of Directive 2001/83/EC
Information Officer according to § 74a AMG
Wholesale representative according to § 52a AMG
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We are here for you!

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Office

Thaerstraße 4a
47533 Kleve

Opening hours

Mo-Fr: 8:30 a.m. – 1:00 p.m.
Mo-Fr: 2:00 p.m. – 4:30 p.m.

Phone

+49 (2821) 7277-0