Software Selection
Driven by increasing regulatory pressure and competition, pharmaceutical companies are starting to adopt PLM (Product Life Cycle Management) software.
Choosing the right software can be a challenge. QbD’s experts will find a tailor made solution for your business.
Software requirements during the life cycle of a pharmaceutical drug
The best suitable tools for the whole product life cycle can reduce time to market, reduce cost, improve quality, optimise processes and reduce waste, utilizing workflows.
Regulatory Affairs
- eCTD
- Document Management
- SOPs
- Life cycle management
- Change control
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Artwork and labelling
- Document management (e.g. EDMS)
- Change Control (e.g Trackwise)
Pharmacovigilance
- Document management (e.g. EDMS)
- Change Control (e.g Trackwise)
- Eudravigilance database (E2B complaint)
- Gateway transmission mode
- EVWEB (Web trader)
- MedDRA (Medical Dictionary for Regulatory Activities)
Clinical trials
- Document management (e.g. EDMS)
- Change Control (e.g Trackwise)
Change control
- Document management (e.g. EDMS)
- Change Control (e.g Trackwise)
How we support you
- Determine user requirements
- Advise on appropriate software
- Guide and coordinate software installation and validation via suitable vendors
- Train your professionals
- Write SOPs
Why QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS​
10+ years of experience
Benefit from our team of highly qualified consultants. ​
Full life cycle support
Full support from pre- to the post-marketing phase.​
Global presence​
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.​
Customer satisfaction​
Constant evaluation, transparency and clear objectives.​
Contact us
TALK TO AN EXPERT
Contact us for more information or to request a free, no-obligation proposal.
