Profil’s GMP-certified pharmacy

GMP-certified pharmacy and manufacturing services

Profil can provide you with a whole range of services in the field of clinical trial management. We have a full GMP manufacturing license for investigational medical products (IMP). Our team is dedicated to manage your clinical trial needs.

Our strengths

Find out how Profil can help you simplify your operations, regardless of how your study is designed.

1. Fast and efficient service

As Profil has specialized on early phase studies, where often very few units are needed, we are able to manufacture IMPs in small scales (e.g. up to 100 units). Profil can adapt to your tight deadline and delivers top quality in labelling and packaging.

2. Flexible to adapt to your needs

Our experts of IMP listen to your needs at every step of the process. We deliver in accordance to your needs and clinical trial requirements. Our strength is our flexibility in production volume. We can produce very short shelf life IMPs (<72 h) on demand and ship them within the EU.

3. Strictly controlled environment

Our facilities at Profil are specially designed to create an ideal environment for pharmaceutical packaging and manufacturing. We have several cleanrooms for manufacturing, packaging and labelling of IMPs with a total area of 123 qm. Our GMP facilities are under regular supervision of health authorities. We have passed several audits by our clients as well as EMA, FDA and our local competent authorities.

Pharmaceutical services

GMP Manufacturing of sterile dosage form
Manufacture of liquid oral dosage forms (solutions, suspensions)
Manufacturing of capsules
Filling, packaging and labeling of oral and solid dosage forms from bulk
Supply of comparator drugs
Controlled distribution of IMPs to study-centers
Import of medicinal products from non-EU countries to be used as IMPs (incl. comparators) in clinical trials
Development of IMP formulations in cooperation with partners
Destruction of IMP can be done by Profil after approval by respective parties
Storage capabilities: Large facilities for storage at room temperature, 2–8°C, -15–20°C and +15 to +25°C with continuous temperature monitoring system (incl. 24 h alarm function).