Industries.
Life Sciences Consulting.
Experienced?
Efficient?
Holistic?
Optimize your processes and meet all requirements.
Life Sciences Consulting - Holistic consulting for sustainable success.
We support you in a targeted manner with customized consulting formats such as Project Consulting, Hybrid Consulting and Strategy Consulting. Our experts know the specific challenges in pharmaceuticals, biotechnology, medical technology and in-vitro diagnostics inside out and develop solutions that are precisely tailored to your needs.
From strategic planning and regulatory approval through to operational implementation, we provide you with expert support in all project phases. We attach particular importance to minimizing regulatory risks, sustainably optimizing your processes and increasing efficiency in the long term.
Benefit from our comprehensive knowledge of the industry and our practical experience to bring your products to market safely, successfully and in compliance with regulations and to secure your long-term competitiveness.
Your challenges - our industry expertise.
Medical technology.
- Advice on and implementation of EU MDR requirements
- Clinical evaluations, CER preparation and clinical affairs
- Quality management according to ISO 13485 and CAPA implementation
- Risk management and usability engineering according to ISO standards
- Approval of software-based medical devices (SaMD)
IVD.
- IVDR certification and regulatory compliance (EU & FDA)
- Quality management systems according to ISO 13485 especially for IVD
- Process validation and quality control in production
- Support with product development and clinical performance evaluation
- Integration of digital solutions for process monitoring and optimization
Pharma.
- Regulatory approval strategies and dossier preparation
- GMP/GxP compliance, quality management and CAPA systems
- Process optimization and lean manufacturing in pharmaceutical production
- Clinical trial management and pharmacovigilance
- Digitization and data integrity according to regulatory standards (e.g. FDA, EMA, ICH)
Biotech.
- Process optimization, automation and sustainable production
- Regulatory compliance for gene and cell therapies
- Technology transfer and production scaling
- Sustainable process design and energy efficiency
- Strategic market entry and international growth
Ensure efficiency and compliance with Life Sciences Consulting!
Discover our sectors in Life Science.
Case Studies - Successful consulting projects in all life science sectors.
Challenge.
A leading pharmaceutical company had to bring a new drug to market under strict time pressure and with limited resources. Internal processes were inefficient and compliance with strict regulatory requirements was a major challenge.Measures.
- Introduction of an agile project management approach to improve flexibility in the development phases.
- Support in the preparation and submission of regulatory documentation in accordance with EMA and FDA requirements.
- Work closely with internal teams to optimize coordination between departments.
- Conduct training for the team to ensure compliance with GxP regulations.
Results.
- The drug was launched on time and received approval in both the EU and the USA.
- The efficiency of internal processes was increased by 25 %.
- Internal communication and cooperation between departments improved significantly.
Success.
The successful market launch of the drug led to a 35% increase in sales. Agile project management was extended to other projects in order to sustainably improve efficiency.Advance your life science projects!
Discover our life sciences solutions.
Hybrid Consulting.
Our hybrid consultancy combines in-depth analysis and solutions with the efficiency of operational excellence.
Project Consulting.
Find the right project consulting expert for your pharmaceutical and medical technology project now.
Strategy Consulting.
Our customised life sciences consulting makes you fit for future challenges.
