APS Pharma Solutions, LLC
Advanced . Precise . Strategic
Delivering the Results that Matter
Regulatory . Labeling . Consulting
About us
APS Pharma Solutions is a consulting company that offers regulatory labeling solutions to pharmaceutical clients.
We work together with the client to understand the specific needs of every project and can customize services to meet unique project requirements.
Our mission is to deliver the highest quality solutions in challenging regulatory scenarios across the globe and working under the tightest of timelines.
Specialty Areas
- Infectious Diseases
- Oncology
- Gastroenterology
- Immunology
- Hematology
- Neuroscience
- Vaccines
- Rare Diseases
- Pain management and Allergy
Solutions
Optimized regulatory Labeling solutions from inception to implementation including the following but not limited to:
- Target Product Labeling (TPL)
- Summary of Product Characteristics (SmPC)
- User Testing
- Implementation of Core Labeling in Regional Labeling
- Labeling Competitive Intelligence
- Company Core Data Sheet (CCDS)
- Patient Labeling
- Readability Testing
- Labeling Negotiations with the Health authorities
- United States Prescribing Information (USPI)
- Instructions of Use
- Labeling Process Development
- Labeling Deviations Tracking
Resources
Labeling guidance and other useful educational materials