The Force CT GmbH

Not all roads might lead to offering your pharmaceutical on the EU market, but there’s more than one path you can take. Let us walk you through the possible routes, timelines, and the most important things to consider with 🛒 MA purchase, 🛒 MA application & procedure, and 🛒 establishing a supply relationship. And no matter which way you choose, our experienced team at The Force CT GmbH is here to travel it together with you – simply reach out to us now.

Obtaining a CE certification for your medical device is just a whisker away – if you can demonstrate its safety. 🐈 Medical devices, whether for diagnosis or treatment, often are in direct contact with living tissue – in cases like implants over long periods of time. And even with indirect contact only, devices have to be designed to guarantee they don’t have any negative impact on the human body. Manufacturers therefore are required to perform a biological evaluation of their product before placing it on the market. Our experts on the development of medical devices and toxicology take chemical, physical, and biological properties of the device into account. Following the standards on the various aspects of biocompatibility addressed in the ISO 10993 framework, we provide the best possible approach to evaluate the biological safety of your medical device, placing special emphasis on: 🐾 substances which are carcinogenic, mutagenic, or toxic to reproduction, 🐾 endocrine-disrupting substances, 🐾 infectious and microbial contamination, and 🐾 devices containing derivatives of tissues with animal or human origin. Contact out team at The Force CT GmbH and let’s ensure the highest possible level of safety and performance of your medical device together.

Do you want to perform a Transformation? Stop doing slides. We Support Your Journey!!!! Hands on!

A full transformation of a business that’s not yet a pharmaceutical company into a pharmaceutical wholesaler – sounds a bit like magic at first. 🪄   In reality, there might be no spells to create a shortcut, but with the appropriate experience and the right approach, you can still conjure up the necessary measures to reach that goal.   And sometimes, the biggest trick is simply not to do it alone.   Just starting out in the European market with only a physical office being established so far, our client was naturally facing ✨ critical gaps in regulatory knowledge and the lack of an established QMS, ✨ absence of qualified personnel in key quality roles, ✨ operational inefficiencies, for example caused by limited knowledge of the GDPR, staffing issues, and insurance requirements.   All of these issues can easily lead to delays, increased costs, and missed commercial opportunities if they aren’t addressed properly, so they asked us to step in.   Learn more about how we put our #THEFORCE approach to work to secure growth and compliance, and ultimately transformed the business into a pharmaceutical wholesaler – even without any actual witchcraft.

It’s easy to get lost in the #outsourcing process, especially when taking the leap from diagnostics, planning, and creating outsourcing capability to the actual implementation stage.   Luckily, from our experience, there are ways and means that help you stay on the right course, and Christian Stenske and Valentin Degenhardt are happy to share them with you. 🌌    In the current issue of #pharmind, they continue to give insights into “Outsourcing in the GxP environment: From Theory to Practice” – this time with even more focus on the practical aspect:   Part 2 of the article centers on finding balance during the outsourcing implementation phase, namely between pharma-specific regulations and the necessary freedoms for an outsourcing partner that’ll allow them to provide effective and efficient services.   Join them on the path that covers everything required to put things into action, including: 🪐 Building on previously established outsourcing capability 🪐 Identification and tendering of potential service providers 🪐 Qualification and conclusion of relevant contracts 🪐 Onboarding of outsourcing partners and starting day-to-day business   Sounds like the guide you need? The full article (in German) is available in pharmind 06/25 – or you can ask us for directions directly: simply get in touch with our team at The Force CT GmbH now.

How do you make sure your outsourcing project doesn’t get out of control? 🌪️   Both the preparation and the actual implementation of outsourcing packages to external partners involve quite a few challenges and areas of tension.   To best address – and resolve – them, the strongest basis is a coherent theoretical concept, combined with practical experience and results-oriented structures.   This is exactly where our live webinar in cooperation with ALPHATOPICS GmbH starts: Valentin Degenhardt will guide you through the important phases of diagnostics and establishing of outsourcing capability within your organisation, as well as the actual implementation and onboarding.   Including everything from definitions, new perspectives, and not least the best practical relevance shown through anonymised examples from our customers, you’ll be best prepared for the outsourcing of services in various fields of activity.   📍 Online webinar 📅 September 10, 2025 | 09:00 – 12:15 🇩🇪 in German   ▶️ Sign up and secure your spot here: https://lnkd.in/e5ckEpNT

What’s scarier than an upcoming inspection? An upcoming PV inspection! 👻   It doesn’t have to be, though: If you’re getting nervous about whether you are safe to pass, #THEFORCE is here to best prepare you for the occasion.   Our team has specialised in supporting you to reach inspection-readiness by: 🪶 cross-checking your PSMF and the processes described, 🪶 controlling the reporting system of adverse reactions, 🪶 checking the Pharmacovigilance quality documentation and SOPs, 🪶 making sure secure Pharmacovigilance Agreements are in place.   But no matter what ruffles your feathers, we are here to assist you in establishing exceptionally Pharmacovigilance in your company.   Get in touch with us now and face your next PV inspection with confidence.

☀️ It’s that time of the year again where a lot of summer (solstice) celebrations are happening in the northern hemisphere, and with our team being from so many different places, a lot of them are celebrated by at least someone at #THEFORCE. Today (and tomorrow), we want to wish our colleagues in Porto – and everyone who gets the chance to join in – particularly joyful festivities. No matter if you’re already gathering at the riverside, are looking forward to some grilled sardines, or simply are excited for the spectacular view of traditional paper balloons and the fireworks lighting up the sky: Happy Festa de São João do Porto! 🎆

Cross off cross-contamination from your checklist! 🐙 When you’re producing your pharmaceutical in a multi-product facility, there’s always a risk of cross-contamination. Luckily, there’s always a first step to minimise this danger, as well: PDE reports give you an insight into how many residues of a certain substance could technically still be in the used equipment without causing any harm. To craft this essential document properly, our Toxicology team at #THEFORCE follows the official European Medicine Agency guideline (EMA/CHMP/ CVMP/ SWP/169430/2012) to determine PDE values and create the respective report. Therefore, our determination of the PDE involves: 🐡 hazard identification by reviewing all relevant data 🐡 identification of 'critical effects' 🐡 determination of the no-observed-adverse-effect level (NOAEL) 🐡 careful use of several modifying factors to account for various uncertainties.   We provide a large pool of existing PDE reports, but we’re more than happy to create one for an API or route of administration that’s not part of our portfolio already – simply get in touch with us to discuss the details.

You want it all, and you want it now? 🪐 That’s what our comfort option Company As A Service is for. What exactly is behind it? Watch our video summary to find out who this service is best for, and what we’ll do to make sure you’re ready to take off with your business in the pharmaceutical, medical device, or healthcare industry. ☄️ #THEFORCE