Assessment of medical and pharmaceutical products

Pharmaceuticals: approval and development

Do you produce pharmaceuticals or pharmaceutical products or are you currently planning new projects? In drug development and release analytics, OFI specializes in addressing chemical and physical issues. In addition to stability studies, we perform degradation studies as well as particle checks. Method development and validation as well as the elucidation of unknown substances complete our range of services. Our experts at the OFI support you in the development or approval of classical chemical active ingredients and biopharmaceuticals, but also in questions concerning products on the market.

Our services (QM system: GMP)

Drug development and release analytics
Stability and degradation assessment studies
Analytics of proteins and biopharmaceuticals
Method development and validation for analytical problems
Expert Center: Particle testing
Clarification of unknown substances and particles

Packaging for medicines

Do you want to submit a drug for approval together with a pharmaceutical package? To ensure that there is no negative impact on your drug product from the packaging, compliance testing, extractables and leachables (E&L) studies, and CCI testing are performed at OFI. To protect your products, we offer both physical and chemical tests on packaging and investigate their interaction with the drug.

Our services (QM system: GMP)

Conformity tests according to Pharm. Eur. and USP
Extractables and Leachables Studies
Container Closure Integrity (CCI)

Testing, development and approval of medical devices

Whether in the context of development, during the approval of medical devices or for products already on the market. We are happy to test your medical devices for biocompatibility using non-animal in vitro methods as well as chemical analysis methods. Our experts perform aging and stability studies as well as degradation and particle testing studies for many different materials such as plastics, metals but also degradable biopolymers.

Our services (QM system: ISO/IEC 17025)

Biocompatibility according to ISO 10993
Chemical characterization
Degradation studies
Stability and aging studies (shelf life)
Expert Center: Particle testing
Expert Center: Hyaluronic acid and gels

Assess compliance with hygienic requirements

Based on years of experience in the development of innovative hygiene concepts, we act as a competent partner for our customers. Whether we are testing the compatibility of disinfectants with the material, or the use of biocide-equipped antimicrobial materials, or assessing the elimination of airborne biogenic hazards. We convince with experience, competence and fast execution.