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
