Regulatory Compliance
The pharmaceutical and medical device industries are highly regulated sectors. QbD’s life sciences experts help you to achieve full compliancy.
Align with regulations
The pharmaceutical and medical device industries are highly regulated sectors. Keeping abreast of current and evolving regulations and standards is a challenge in today’s fast moving environments and changing regulatory landscapes.
Over the years, the pharmaceutical industry has become one of the most highly regulated, second only to the nuclear and aerospace industries. The need for regulatory compliance has thus also gained in importance. Compliance is about developing and implementing internal controls and procedures that promote adherence to applicable statues, regulations and directives and other regulatory requirements1.
1) Office of the Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers., April 2003, Federal Register/Vol. 68, No. 86/ Monday, May 5, 2003/Notices.
How we support you
- Implement written procedures and policies (SOPs)
- Conduct effective training
- Internal monitoring and auditing
- Execute specific compliance related projects (artwork changes, software implementation, validation and training, technical files and dossiers)
- Implement pro-active compliance projects
Why opt for the QbD Group?
⟶ Expert Advice from our team of business consultants
10+ years of experience
Benefit from our team of highly qualified and experienced business experts.
Global presence
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Eye level communication
Clear and transparent objectives, and constant evaluation.
Contact us
Talk to an expert
Contact us for more information or to request a free, no-obligation proposal.