Launch & Inspection Readiness

A well-organized launch is crucial for success, and without careful planning, the risk of failure is high. However, these risks can be averted with a professional implementation strategy including adept project and crisis management. Effective and seamless collaboration amongst market access, regulatory, supply chain, and quality departments will ensure the success of your product launch.  

We offer comprehensive support for your start-up, ranging from strategic planning to detailed quality work and WDA inspection guidance, ensuring a smooth product launch in Germany.  

Start-up Guidance & Site Establishment

Regardless of whether your product is a biological, a medical device or an orphan drug, we support you in analyzing your current strengths and weaknesses whilst also identifying potential risks associated with your planned launch. The emphasis extends beyond GDP aspect, encompassing a thorough examination of the company‘s local administrative specifics and areas such as regulatory, pharmacovigilance, market access and logistics.

Audits & Inspections

In order to be able to trade in pharmaceuticals in Germany, a wholesale permit is often a prerequisite. We are happy to assist you in applying for a WDA (Wholesale Distribution Authorization) at the appropriate state authority and to guide you successfully through the inspection. The development of a GDP-compliant quality management system, the provision of the responsible person according to §52a AMG or even support during the inspection are no problem for us.

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