Advice on marketing authorisations
“The ever-increasing requirements for pharmaceuticals must be addressed through optimal use of resources as part of a systematic regulatory strategy. Successful approval of your product requires regulatory certainty.”
We develop scientifically sound and regulatory-compliant strategies for preclinical and clinical requirements.
We formulate trial protocols and study designs for clinical efficacy and safety evaluations in close collaboration with you, as well as with qualified and vetted contract research organizations (CROs), biostatisticians, and physicians.
In doing so, we also take into account pediatric use within the Paediatric Investigation Plan (PIP) and current HTA (Health Technology Assessment) requirements.
Coordinating and supporting clinical projects through scientific advice procedures with European regulatory authorities is a key milestone in your project.
We handle the following on your behalf:
Regulatory Strategies: Analysis of regulatory opportunities and hurdles
Authority Meetings (e.g., Scientific Advice)
Preclinical and Clinical Overview Reports (Modules 2.4 to 2.7)
Pediatric Medicinal Product Consulting
PUMA Applications
Preparation of Paediatric Investigation Plans (PIP), Waivers, and Deferrals
Labelling
Marketing Authorisation Applications and Lifecycle Management
Compilation of the Quality Section (Module 3, Module 2.3)
Our project management accompanies the entire process from strategy development—including the Paediatric Investigation Plan (PIP)—to the integration of results into the marketing authorization application.
Your Benefits:
Over 25 years of experience dedicated to your project
Development of tailored strategies
Planning certainty through alignment with regulatory authorities via Scientific Advice
Our persistent objective: Streamlining the clinical development program
Professional project planning and timely project management from clinical trial to marketing authorization