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From drug discovery to
post-marketing-commitments

CMC –
bringing compounds to life

We have the capabilities to deliver innovative technical solutions – including for complex molecules.

Our expertise includes:

  • capabilities to develop sophisticated formulations for pre-clinical and first-in-human trials
  • full analytical development services for drug development
  • capabilities to develop cutting edge formulations for our patients, e.g., capsules, liquid solutions, patches, or suppositories
  • fast upscaling to serve large, worldwide clinical trials and initial market entries while maintaining highest quality levels

NTEs –
making a difference with existing products

NTEs are our strategic focus for Latin America.

Our NTE team creates innovation for our patients focusing on established drugs and technologies. To foster innovation, we develop models for early proof of concept.

Our expertise includes:

  • reformulations of established products
  • repurposing of established products
  • new combinations of established drugs and medical devices

 

Data sciences –
harnessing the power of data to drive innovation

We have experts who are able to transform data into knowledge, decisions and values.

Did you know?

Our data scientists sit in one, single team, and are located at one site. They contribute centrally across all phases of pre-clinical and clinical development, with data coming from all therapeutic areas. The team have a range of backgrounds from mathematics and statisticians, to physics and engineering.

Our expertise includes:

  • model and simulate data for a new dose, population, or formulation, where simulated “virtual patients” can substitute for a Trial
  • design of clinical development plans and trials – define their criteria and calculate the probability for success
  • management and analysis of data from small datasets to big data (billions of data points)
  • standardization and submission of data to regulatory and pricing authorities
 

Regulatory Affairs –
always adding value

As a strategic business partner, our state-of-the-art knowledge accelerates time to market and maximises development and market success.

Marketing authorisations
5,000

Maintaining approx. 5,000 marketing authorisations worldwide

New submissions
1,100

Carried out more than 1,100 new submissions in the last 5 years

“First-cycle” approval
97%

Successful “first-cycle” approval in >97% of all submissions

Patent applications
30

Manage around 30 new patent applications per year

Our expertise includes:

  • excellent reputation with regulatory authorities in EU and beyond
  • knowledge at forefront of new regulatory trends to shape and prepare for new standards
  • global capabilities and network to ensure worldwide marketing authorisations and their maintenance