Our perspective and approach are different: we see regulatory compliance and the overall quality structure as business issues first and foremost; providing a regulatory observation without the business context is like serving coffee without a cup.® Our strength is about applying business and common sense principles to operations in the pharmaceutical and related life science industries. While a number of such operations are subject to regulations, all of them should be performed using good business practices.
What we do
Our Capability Statement provides details on the core areas of our expertise and how they form the basis of our consultancy, as well as information regarding our client base.
Where compliance/quality, operations and business risk come together, as they always do, we provide practical regulatory compliance/quality-oriented solutions and identify core operational problems which are the root of the regulatory compliance and quality infrastructure deficiencies.
We help to secure and/or maximize your business’ profitability through:
- Identifying and assessing your business risks within the regulated environment.
- Simplifying the establishment, enhancement, remedy and maintenance of operational efficiency and effective regulatory compliance (cGXP).
- Training your staff in the process and providing them with additional skills they need to be more efficient in your environment.