Medicilon exists FDA inspection: milestone for research excavator!

Medicilon exists FDA inspection: milestone for research excavator!

Shanghai, China - Medicilon Preclinical Research (Shanghai) LLC reached an important milestone on May 20 by successfully passing the FDA inspection on site. This inspection stretched over various decisive areas, including the organizational structure, the qualification of the staff and the integrity of the facilities. As reported ots, the company received an official operating inspection report (established inspection report-eir).

The FDA inspectors checked several research projects that had previously been submitted to the authority. Medicilon was praised for his scientific discipline and operational excellence. This inspection was the first of its kind for Medicilon after seven years and increases the regulatory credibility of the company enormously. Success in the inspection opens up new perspectives for cooperation with authorities and partners.

research and development strengthen

Medicilon, which was founded in 2004 and offers extensive research and development services for pharmaceutical companies, has already approved more than 520, however, for clinical exams by the end of 2024. These include 34 antibodies, 28 ADC medication, 8 GLP-1 medication, 6 Protac medication and 3 vegetable medicines. This illustrates the commitment of Medicilon in the Pharmaf research , which identifies and developed new active ingredients and medicines for different therapeutic areas.

In order to ensure the quality and security of new medicines, these must be tested in preclinical and clinical studies. The process of pharmaceutical research, which usually lasts 14.2 years, includes several phases in which active ingredients are checked for their effectiveness and harmlessness. However, the average success is low: out of 10,000 evaluated active substances, about five only reach clinical research, and only one receives approval.

growth and innovation

Due to the successful inspection result, Medicilon plans to further deepen his investments in research and development. The aim is to promote innovative and high -quality solutions for the global pharmaceutical industry. The inspection results not only underline the technical competence of the company, but also the potential to increase the productivity of pharmaceutical research and at the same time to master the challenges in drug development.

Developments in pharmaceutical research are essential because they affect not only the quality of life of many people, but also the economic performance of the companies involved. Medicilon’s commitment to offer innovative F&E services and at the same time meet the regulatory requirements, positions the company as an important player in the international pharmaceutical industry.