The Medfiles Pharmaceutical Chemical Expert Team – or the CMC Team in short – is all about chemistry, manufacturing and controls. We are a group of six experienced and enthusiastic experts with academic backgrounds in pharmacy, chemistry and chemical engineering. Everyone in our team has a long and diverse hands-on experience in the pharmaceutical industry in various roles, including product development, production, analytics, regulatory affairs, project management and QA. Our experience covers sterile and non-sterile human and veterinary products as well as various regulatory and technology transfer activities.
We support our clients in their pharmaceutical product development by participating in and coordinating development activities and planning the studies needed to meet regulatory requirements. In practice, this can be for instance writing process validation and stability study protocols and reports or analytical method transfer protocols. We also write Module 3 and Part II documentation and Quality Overall Summaries. When quality changes have to be made to products during product lifecycle, we help our clients determine the appropriate variation categories and prepare the required documentation to support the change. As part of product maintenance, we prepare risk assessments and continuous process verification reports. Our assignments vary from short-term consultation to complete quality dossiers or pharmaceutical development projects. In addition, we provide support for active substance manufacturers by compiling the documentation needed for certificates of suitability (CEP) or active substance master files (ASMF).
We are very flexible in how we work. We can work at our clients’ premises according to their SOPs or from the Medfiles office utilising our document sharing platform and document templates. Our resources always come with guaranteed back-ups, which means that we are here for our clients also during holiday seasons.
Companies approach us mainly for two reasons. Firstly, they might not have the specific competence needed for the task at hand in-house, and secondly, their experts might be busy with other tasks, which means that they simply need an extra pair of hands – and an extra brain. Each case is different, and we do our best to tailor our services according to what is needed.
We are passionate about our work. It is motivating to get to work with professionals with a similar kind of mindset, and our work always offers plenty of opportunities for continuous learning. At Medfiles, we are surrounded by 150 professionals in R&D, drug product manufacturing, analytical chemistry, QA, regulatory affairs, pharmacovigilance and clinical studies. Our strong in-house expert network works flexibly together, and as a team, we cover the entire CMC. When you work with one of us, you will benefit from the know-how of the entire company.
To know more, please get in touch on LinkedIn or send us an email!