Pharmacovigilance Outsourcing Services: How and when for Global Pharma, Biotech, and CROs
Pharmacovigilance Outsourcing Services: How and when Global Pharma, Biotech, and CROs Strengthen Safety, Compliance, and Regulatory Success In today’s highly regulated environment, pharmacovigilance outsourcing services have become a strategic necessity for pharmaceutical companies, biotech organizations, sponsors, and CROs operating across the US, EU, UK, and APAC markets. As safety data volumes increase and global regulatory […]
Strategic ICSR & Literature Surveillance Consulting for Global MAHs (US, EU, UK)
Global ICSR Consulting experts & Literature Surveillance specialists for Global MAHs (US, EU, UK) From compliance risk to inspection-ready operations GPLACO SOLUTIONS are one of the top ICSR consulting experts specializing in ICSRs processing and Quality management for the USFDA, EMA and MHRA processes, we help MAHs and Sponsors transform complex ICSR workflows into compliant, […]
AI Regulatory Submissions: A Pharma Case Study
Case Study: Optimizing AI Regulatory Submissions In this case study, we explore how AI Regulatory Submissions helped a top-tier pharma client reduce their filing preparation time by 40%. By utilizing Natural Language Processing (NLP), we automated the extraction of data from clinical study reports. The Impact of AI Implementing AI Regulatory Submissions allowed the […]