Our company consists of professionals who are specialized in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Clinical Supply Management. Also they are competent in several languages and can act as Qualified Persons (QP), which make them able to accommodate all different types of clients with preparation of documentation and advice in quality assurance, clinical trials, logistics and supply.
A Qualified Person is the term used to describe a person, who is qualified to certify a medicinal product for sale and supply or for use in a clinical trial in the EU. The QP makes sure that the batch of the medicinal product has been manufactured according to relevant requirements. Our QPs have several years of experience working with pharmaceutical manufacturing operations and has the necessary insight in the international developments in the field.
GMP regards to the practice of accommodating the rules and guidelines recommended by authorities which control the licensing for manufacture and sale of pharmaceutical products. With GMP we make sure that all the requirements are met so that the quality of the product lives up to the standards laid down by the regulatory agencies.
With Quality Assurance we make sure that any mistakes or defects in the manufacturing process are prevented. In that way our clients can avoid potential problems in their solutions and services. This means that with QA we can verify the pharmaceutical product and ensure that it follows all requirements specified by quality controls. The task is a part of the administrative practice and is therefore implemented in the strategic system.
GDP is a system, which guarantees the quality of the distribution process. This covers everything from the requirements for purchase, storage and imports are established to control and organize all logistic aspects of the distribution of pharmaceutical products. By complying with GDP requirements we can make sure that the quality of the product is maintained throughout the distribution.
We offer GxP Audits where we monitor your quality system and ensure that the manufacturing and/or distribution process complies with the requirements and regulations set up by the authorities. Today audits are seen as a necessity in the pharmaceutical industry and should be implemented as a routine activity. Audits also play a key part in clinical trials to make sure that the IMP are manufactured/supplied with the utmost care and comply with GMP and GDP requirements for investigational medicinal products. These audits can be implemented in both the development stage of the product or during the conduct of the trial.