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

  • Oncology
  • Immunology
  • Vaccines
  • Infectious Diseases
  • Hematology
  • Rare Diseases
  • Gastroenterology
  • Neuroscience
  • Pain management and Allergy
  • Cell and Gene Therapy

Solutions

Optimized regulatory Labeling solutions from inception to implementation including the following but not limited to:

  • Target Product Labeling (TPL)
  • Company Core Data Sheet (CCDS)
  • United States Prescribing Information (USPI)
  • Summary of Product Characteristics (SmPC)
  • Patient Labeling
  • Instructions of Use
  • User Testing
  • Readability Testing
  • Labeling Process Development
  • Implementation of Core Labeling in Regional Labeling
  • Labeling Negotiations with the Health authorities
  • Labeling Deviations Tracking
  • Labeling Competitive Intelligence

Resources

Labeling guidance and other useful educational materials

Contact us

Kamana Singh, DVM,MS,MBA,RAC(US)

APS Pharma Solutions is just a click away!

I am also available at following
Email: kamana.singh@apspharmasolutions.com

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