The pressure to be efficient and successful increased continuously in pharmaceutical and biopharmaceutical industries during the last decade. In addition, in the interest of patients regulatory hurdles became higher and higher leading to the need for more data, higher data quality and full regulatory compliance to achieve successful submissions, with this rising the drug development efforts, i.e. time and cost. In parallel the demand for cost reduction increased, which is mainly counterbalanced by e.g. innovation, improvement of processes and increase of efficiency, reduction of headcount and more outsourcing.
We aim to support our clients to deliver results obtained either in-house or from CROs at highest quality with state-of-the art technologies, following best scientific practices and in compliance with current regulatory requirements and company policies for successful dossier submissions and product launches.
Our key experiences and consultancy services cover:
- (Bio)Analytics by chromatographic and hyphenated techniques, e.g. LC-MS/MS
- Pharmaco-/Toxicokinetics (PK/TK)
- Outsourcing support
- Independent unbiased expert opinion
- Scientific writing and peer reviews
- Process analysis and improvement
- Scientific event organization
- Interim management