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
Company Details
- Employees
- 7
- Founded
- -
- Address
- 4 Cruiser Court, Hillsborough,new Jersey 08844,united States
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- pharmaproconsulting.com
- HQ
- Hillsborough, New Jersey
Pharmapro Consulting Questions
Pharmapro Consulting's website is pharmaproconsulting.com
Pharmapro Consulting's LinkedIn profile is https://www.linkedin.com/company/pharmapro-consulting
Pharmapro Consulting has
7 employees.
View email and phone details for 7
employees at Pharmapro Consulting.
Pharmapro Consulting's industry is
Biotechnology Research
Pharmapro Consulting's top competitors are
Vijay Group Infra,
Project Dontabhaktuni,
Regkey,
Med Discovery Sa,
Pharma Pro,
Equality, Period. Nj,
Pharmapro,
Eli Lilly And Company,
Shiv's Third Eye,
Equantx Pharma Analytics Solutions.
Pharmapro Consulting's categories are Biotechnology Research
Pharmapro Consulting's founding year is 2015
