Digital Post Approval Services

PLG’s Digital Post-Approval Services deliver targeted digital transformation solutions for highly regulated GxP environments. 

Our expertise spans Regulatory Affairs, Pharmacovigilance, Project & Portfolio Management, Quality Assurance, Laboratories, Manufacturing, and Supply Chain & Serialization. We design, implement, and support validated digital platforms, including Regulatory Information Management Systems (RIMS), electronic manufacturing records, and automated safety database solutions. 

By replacing fragmented, spreadsheet-based processes with integrated and automated digital solutions, we help organizations improve efficiency, strengthen compliance, and enhance cross-functional collaboration. 

With over 25 years of industry experience, our proven frameworks protect GxP data integrity, reduce operational complexity, and support continuous regulatory readiness. 

We evaluate every transformation project through five specialized lenses to ensure digital solution deployment delivers direct business and compliance value: 

• Operational Excellence: Mapping and optimizing GxP workflows to remove bottlenecks and maximize daily productivity.  
• Information & Data: Structuring data flows to establish a validated, single source of truth for reliable business metrics and audits.  
• Digital & Tech: Identifying and configuring functional, market-leading software architectures tailored to complex enterprise needs.  
• Proactive Compliance: Integrating computer systems validation (CSV) and data integrity safeguards directly into the delivery lifecycle, from initial system scoping through to decommissioning.  
• Sustainability: Ensuring operational green-by-design principles to secure long-term viability across corporate and industrial sites. 

• Regulatory Affairs

Replacing disconnected data systems with unified Regulatory Information Management Systems (RIMS), Document Management Systems (DMS), and Master Data Management (MDM). We streamline the data foundations needed for global renewals, variations, and active IDMP compliance.  

• Pharmacovigilance & Safety

Improving multi-vigilance oversight by automating safety case intake, processing, and electronic submissions using advanced automation and Machine Learning. We implement secure cloud and on-premises Drug Safety Management Systems (DSMS) to eliminate manual burden and consolidate reporting analytics.  

• Quality Assurance

Modernizing document lifecycles to compress quality record processing times. We deliver fully validated digital environments covering Quality Management Systems (QMS), Document Management (Quality DMS), Training Management (TMS), and paperless validation platforms (VLMS).

• Manufacturing Execution

Designing digital production roadmaps aligned with a Pharma 4.0 approach. We implement Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR) to boost throughput, provide fast deviation reviews, and maintain flawless manufacturing data integrity.  

• Laboratories

Optimizing lab efficiency and scientific data compliance by defining, validating, and supporting Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN) and Lab Execution Systems (LES).  

• Supply Chain & Serialization 

Securing products against counterfeiting through comprehensive track-and-trace compliance. We optimize material flows and warehouse management systems (WMS) while aligning international logistics with evolving geographic mandates (including EU, USA, Russia, and the Middle East).  

• Project & Portfolio Management (PPMS)

Establishing a reliable, centralized platform to govern project paths, resource allocation, and corporate investments from early idea evaluation to final execution.  

• IT Service Management (ITSM)

Transforming IT infrastructure qualification and service desk tracking from traditional paper-based methods to fully digital, GxP-compliant workflows.