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Our capabilities | R&D | Grünenthal Group

From drug discovery to
post-marketing-commitments

Translational science

We are striving for excellence in the two-way-translation of pre-clinical data into clinical trials and clinical findings into our basic research efforts.

Our expertise includes:

  • innovative models and biomarkers translatable from in-vitro studies to rodent animal models to man.
  • novel biomarkers and pharmacodynamic models in healthy volunteers
  • innovative pharmacology and proof of concept clinical trial design, including outcome measures

Solutions-focused clinical development

We design clinical programs to address patients’, regulators’ and payors’ demands from early on – irrespective of indication, patient population or therapeutic approach.

Solutions focus:
In brief

  1. We are developing new Patient-Reported Outcome (PRO) measures for specific diseases to meet the needs of payors. We are the only company bringing PRO measures to early development in pain.
  2. Through our tapentadol paediatric program, we are conducting pioneering research and designing special protocols to drive solutions for babies, children and adolescents. We are strongly committed to the unique needs of children and their parents.
  3. In Latin America, we focus on projects to meet the specific needs in that region (pain, women’s health and CNS).

Our expertise includes:

  • holistic clinical trial strategy and planning
  • full clinical trial operations
  • experienced CRO management
  • best-in-class data management, data analysis and modelling, and simulation

Clinical Operations (CO) –
delivering high quality clinical trials

We collaborate with internal and external commercial partners to ensure the delivery of clinical trials in line with timelines, budget, and adherence to the highest quality and ethical standards.

Our Clinical Operations model

We follow a lean model to provide the right level of oversight to studies and programmes in our pipeline, but always strive for maximum efficiency. This allows us to increase speed to market, yet observe the highest quality standards and bring new medicines faster to our patients.
... pipeline

Our expertise includes:

  • clinical trial management
  • clinical trial oversight
  • data and documents operations
  • quality management services and compliance

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