Consulting on Drug Approvals
“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 protocol plans and study designs for clinical efficacy and safety trials in collaboration with qualified and vetted Clinical Research Organizations (CROs), biometricians, and physicians, and in close coordination with you.
In doing so, we also take into account the pediatric use as outlined in the Pediatric Investigation Plan (PIP) and the current requirements for benefit assessment.
For us, coordinating and supporting clinical projects through the Scientific Advice process with European drug regulatory authorities is an important milestone in your project.
We'll take care of the following for you:
Approval Strategies: Analysis of Regulatory Opportunities and Obstacles
Discussions with regulatory authorities (e.g., scientific advice)
Preclinical and Clinical Regulatory Reviews (Modules 2.4 through 2.7)
Advice on Children's Medications
PUMA Certifications
Preparation of a Pediatric Investigation Plan (PIP), Waiver, and Deferral
Labeling
Regulatory Filing and Maintenance
Completion of the Quality Section (Module 3, Module 2.3)
Our project management team supports the entire process, from strategy development—including the Pediatric Investigation Plan (PIP)—through to the incorporation of the results into the marketing authorization application.
Your benefits:
Over 25 years of experience for your project
Developing Tailored Strategies
Planning Certainty Through Coordination with Authorities via Scientific Advice
Our ongoing goal: Streamlining the clinical development program
Professional project planning and on-time project management, from clinical trials to regulatory approval