Pharmaceutical Drugs
QbD Austria offers you the complete package to bring your pharmaceuticals to the European and Chinese markets. We support you during the whole product life cycle, from pre- to the post marketing phase.
Our consultants offer extensive regulatory affairs knowledge and expertise to support your team or insource complete regulatory affairs projects – all in an efficient and pragmatic manner.
⟶ from preclinical to clinical (Phase I, II, III) to market commercialization.
Regulatory Strategy
Bringing your pharmaceuticals to the market requires a tailor-made strategy. We help you to form that strategy and make it a success!
Drug Development
New pharmaceuticals are required to be manufactured to high quality standards before they can be placed on the market. We support your from drug discovery to pre-clinical and clinical testing.
Agency Interactions
Sucessfully submit your application for drug approval – we help you to interact with the competent authorities.
Regulatory Procedures
There are various procedures for drug registration, depending on the type of the product and your intended route to market. QbD’s consultants will walk the right path with you.
Submissions
Applications for marketing authorisation must be accompanied by the required documentation. QbD will help you to get your documents right.
eCTD
Compiling eCTDs can take years of training, industry immersion and regulatory study. QbD is your competent partner for electronic submissions.
Artwork and labelling
QbD’s experts help you to compile your artwork and labelling in full compliance with current regulations.
Pharmacovigilance
Have an appropriate system of pharmacovigilance in place, as required within the European Economic Area (EEA).
Life cycle management
QbD’s experts accompany you throughout entire lifecycle of your product – from its conception, through design and manufacture, to service and disposal.
Software Selection
Choosing the most suitable software for your PLM can be a challenge. We will help your to find your tailor made solution.
Information Officer
We provide pharmaceutical organizations with a qualified Information Officer to coordinate their information management and marketing activities.
Why opt for QbD Austria?
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.