Drug development continues to be time consuming, expensive, and inefficient, while pharmacotherapy is often practiced at a suboptimal level of performance. This trend has not waned despite the fact that vast amounts of data are obtained during clinical trials and patient care each year.

We can help you author the clinical pharmacology sections for submission to various health authorities (FDA, PMDA, SFDA, EMA, KFDA, etc) which include:

• eCTDs modules 2.7.1 and 2.7.2
• Question-based Reviews (QbR)
• Clinical Study Protocols
• Clinical Study Reports 
• Investigational New Drug (IND) Applications 
• New Drug Applications (NDA)
• Pediatric Investigation Plans (PIP)
• Pediatric Study Plans (PSP) 
• Orphan Drug Designation Applications (ODD) 
• Breakthrough Therapy Designations Applications

Our seasoned professionals can  address questions relating to Clinical pharmacology, PK, PK/PD, and POPPK from various regulatory agencies across the world.

We can help you develop strategy and execute clinical pharmacology plans, PIP Binding elements, and PSP plans. PharmaPro does this by serving as clinical pharmacology project leader and providing scientific leadership on Biologics, ADCs and combination therapies, in oncology, immuno-oncology, diseases with unmet medical needs, etc.

We can participate in due-diligence and in-licensing activities, conduct market research analyses, and forecast trends. Based on project needs, we can conduct hands-on PK, PK/PD analyses, provide QC-QR of IBs, CSRs, and create health authority submission documents.