Germany.

Based in Lörrach, Germany, our strategic business unit, IL-CSM Clinical Supplies Management GmbH, has become a trusted partner for the healthcare industry in the heart of Europe. We support our clients in the pharmaceutical business both in clinical development and commercialisation through our commercial services. We serve a diverse clientele, including startups, large and small pharmaceutical companies, hospitals and NGOs.

Customised solutions

Clinical supply

We support your clinical trial (human and veterinary medicinal products) with the following activities, whether as a complete service or selected services. Customer needs are always at the centre of our activities. Our strengths are customised and flexible solutions with the highest possible customer satisfaction.

Development of the packaging concept for the production of samples
Procurement of the comparator medication; basic medication and all excipients
Blinding and masking
Primary and secondary packaging of clinical samples
Marking and labelling (incl. randomisation)
EU certification and batch release/QP services (incl. vaccines and sera)
EU central storage/depot of medication, distribution, retrieval and destruction
Allocation of study medication at the patient level
Onboarding of depots in the USA, Singapore and Australia
Pharmaceutical consulting
Supply chain auditing and monitoring
Shelf life extension management

Our key competencies include regulatory assessments for QP approvals and compliance with European and German pharmaceutical law. In addition, we have experience with other economic target regions, such as the US, Switzerland, the UK, Asia and Eastern Europe.

Our broad network also allows us to support you in laboratory analysis, product development and bulk production. We also have experts on hand to assist with any issues relating to medical devices and combination products.

Commercial services

We handle logistics for authorized medicinal products (both human and veterinary) with:

GDP-compliant storage (ambient/cold/frozen)
Transport (ambient/cold/frozen)
Distribution and wholesale
Destructions
EU certification and batch releases/QP services
Audits and monitoring of the supply chain
Handling of retained samples

Our packaging site in Switzerland enables us to expand our range to include primary and secondary packaging for our commercial services.

Quality system and good manufacturing practices

IL-CSM holds essential licenses from local authorities, including:

Import licence for registered medicinal products and clinical samples (each including vaccines and sera) from non-EU countries, issued by the RP Tübingen
Authorisation to carry out EU marketing authorisations for registered medicinal products and clinical samples (incl. vaccines and sera), issued by the RP Tübingen

Standard operating procedures

Our standard operating procedures (SOPs) comprehensively define all operating procedures and ensure that our manufacturing processes comply with applicable GMP regulations. Our staff are trained in GMP rules, and our key pharmaceutical personnel undergo continuous further training by attending conferences and training courses.

Qualification

We qualify our partner companies with whom we work for their activities and products and, where necessary, are checked and regularly inspected by our audits. We are happy to take on these supply chain qualification activities for you or offer you the services of our quality assurance processes for your purposes (e.g. appointing the person responsible for GDP).