Services

Everyone knows the situation: The supervisory authority announces an upcoming inspection. We help you prepare by analyzing your processes and assessing potential risks on the basis of observations from previous audits. Then, if necessary, we suggest ways to reduce the identified hazards.

Using a gap analysis, we identify risk-based short-term measures to prepare for the inspection in your plant and help you implement them. We also support you in formulating satisfactory responses to the supervisory authority as part of the follow-up to an inspection.

Customized key performance indicators (KPIs) are an essential module for monitoring progress in your organization. We work with you to develop meaningful KPIs that enable a reliable assessment of development on the basis of objective criteria.

Pharmaceutical companies are increasingly under fire for inadequately monitoring their quality assurance systems. With our many years of experience, we can show you effective ways to address this potential problem in a targeted manner. As a result, you gain important information on your processes and can initiate continuous improvement mechanisms.

In order to reliably assess your organization's performance and describe possible deficits precisely, we analyze selected parameters that are critical to success. Our analysis is based on best practices and includes suggestions for eliminating potential weaknesses. Right-the-first-time principles and short lead times play an important role here.

We assist you in implementing the findings and any necessary restructuring measures that result from the analysis of your organization or your processes.

In case of an absence at executive level or to initiate changes, we can take over important key functions and strengthen your management team — even at short notice if required.

Consolidation in the pharmaceutical industry continues unabated. This requires aspects of pharmaceutical quality to be intensively examined in all due diligence projects. We assist you with our comprehensive due diligence and GMP expertise.

Managers in the pharmaceutical environment often lack a discussion partner at eye-level to substantiate their own assessments or exchange views on risks to long-term business development. We fill this gap as a coach and "sparring partner".

You can also count on us for operational tasks. If required, we take over audits, self-inspections, product transfers, QP services or in-house training for you.

In the event of short-term bottlenecks in the field of Regulatory Affairs, we manage your project as external consultants. We can also support you during peak periods, for example, when launching medicinal products and maintaining the marketability of your products or assist you in updating or creating product information texts.

We take over information officer (AMG § 74a) activities for you and ensure scientifically correct information about medicinal products.