PharmaPro Consulting

Biotechnology ResearchUnited States2-10 Employees

We are a consulting company. We partner with pharmaceutical and biotechnology to rapidly advance new agents from IND to NDA/BLA.
PharmaPro Consulting offers consultancy services to the pharmaceutical and biotechnology industries. Our expertise is in the areas of:
Regulatory Strategy
Regulatory Submissions
Clinical Pharmacology 
Preclinical, ADME, and DMPK
Pharmacokinetic data analysis
Toxicology/toxicokinetic data analysis
Drug metabolism and Drug-drug interaction studies, Special Patient Population Analyses
Pharmacokinetics and Pharmacodynamics Modeling and Simulation
Population PK Analysis
Data management
 To 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 
To address questions relating to Clinical pharmacology, PK, PK/PD, and POPPK from various regulatory agencies across the world.
To develop strategy and execute clinical pharmacology plans, PIP Binding elements,and PSP plans
By serving as clinical pharmacology project leader and provide scientific leadership on Biologics, ADCs and combination therapies, in oncology, immuno-oncology, diseases with unmet medical needs, etc.
To participate in due-diligence and in-licensing activities
To conduct market research analyses and forecast trends
Based on project needs, we can conduct hands-on PK, PK/PD analyses, conduct QC-QR of IBs, CSRs, and health authority submission documents

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