Innovation und development
Gebro employs all the capabilities of a fully integrated pharmaceutical company - from initial idea to finished product. We focus on patient needs and the requirements of healthcare professionals. We are particularly passionate about partnering with public institutions and private groups to establish new research initiatives and innovation projects at the highest level of excellence.
- Cutting-edge pharmaceutical laboratory capacities
- Development, upscaling and troubleshooting of solid, liquid and semi-solid dosage forms
- Formulation development and preformulation testing
- Transfer to industrial production facilities and support throughout process validation
- Development and validation of all common analytical methods
- Chemical and physical analysis of test batches, preliminary stability and ICH stability tests
- Perpetual improvement of existing products regarding dosage forms and methods
- Consistent implementation of new regulatory requirements
Regulatory support
Regulatory support as required. This covers both new drug approvals and ongoing life cycle management and includes the following activities:
- Development of the regulatory strategy
- Preparation of the dossiers (modules 1 to 5)
- eCTD life-cycle management
- Artwork management
- GSPR evaluations for drug-device combinations
Pharmaceutical analyses
In full control. Gebro has the necessary knowledge and laboratory capacities to ensure that we and our customers can prove compliance with all required quality parameters at any time.
- Incoming quality control of raw materials
- GMP-compliant batch release
- Stability tests
- Development of analytical methods
Medical affairs
Medical expertise on demand. Our partners rely on our know-how in the following areas:
- Pricing and reimbursement
- Medical inquiries
- Medical information manager
- Literature management
Pharmacovigilance
A lot of work simply taken off your hands. Thanks to our experience and established structures, we can assist our partners in complying with regulatory requirements for drug safety.
- Preparation and submission of PSURs
- Preparation of RMPs
- Case management
- Pharmacovigilance contracts
- Signal management
