Anyone who has read them knows that the GMP rules are general, open-ended and leave room for interpretation. They cannot be directly implemented 1 to 1. And this is exactly where the uncertainty of many customers begins: Which regulations are relevant? What is a must, what is a can? How should the requirement be implemented? Which procedure should be chosen and when should it be documented? Which internal areas are affected, what has to be checked and when? One thing is certain: GMP for a biotech facility looks different than GMP for sterile pharmaceutical production. Successful GMP consulting uses the combination of broad competence and experience!

GMP compliance as top priority

Achieve GMP compliance in the shortest possible time. That is the goal of GMP consulting projects. Because deficits in quality assurance can have consequences not only for product quality and thus for the consumer. If a product is not launched on the market in time due to a lack of compliance, massive economic damage is caused. This is where MedCycle-Consulting offers sound GMP experience. We have accompanied a large number of regulatory inspections and prepared, conducted and followed up on audits on their behalf.

It has to be realizable – practice-oriented GMP advice

The best advice is useless if the proposed solutions are theoretical; Far away from practice and ultimately failing due to feasibility and not implementable. The fact that Medcycle-Consulting as a GMP consultant is also involved in the implementation of GMP solutions gives the certainty that proposed solutions and concepts are practical, pragmatic and implementable.

As much as necessary, as little as possible

Who doesn't know it? The fear that consultants, to be on the safe side, will recommend the maximum. >>> Not so with MedCycle-Consulting! The combination of many years of experience in many pharmaceutical areas paired with business understanding enables us to use the resource QUALITY exactly where it is most efficient and effective without compromising on GMP-COMPLIANCE. This is one of our guiding principles and is put into practice in our work every day.

The right advice at the right time

MedCycle-Consulting offers a wide range of consulting support options. Ultimately, it depends on the task and the requirements resulting from the product, process and ongoing project. Generally offered:

• Compliance advice when it comes to general GMP issues
• Concept advice when it comes to concepts for qualification, validation, the QMS and documentation - or holistic GMP concepts
• Consultations in connection with customers or inspections by authorities
• Accompanying consulting when it comes to "looking over the shoulder" during the implementation of GMP measures

Advantages

• Overview of GMP regulations and their requirements
• Solution approaches for the implementation of individual requirements
• Targeted on the product, process and project
• Pragmatic and focused on what is really necessary
• GMP consultant with in-depth expertise of the regulations and many years of practical experience
• Flexible in terms of time and scope
• Cooperative advice with a view to profitability