Pharmaceutical Regulatory Compliance

Intelligent | Agile | Compliant

Pharma Regulatory Compliance

Pharmaceutical Regulatory Compliance

Intelligent | Agile | Compliant

Trending

Trending

The complexities are stemming from continuously evolving global regulatory standards. Manufacturers need to constantly track and align processes to ensure regulatory compliance to the product packaging and regional pack label requirements, submission documentation requirements, pharmacovigilance reporting compliance, and product lifecycle compliances. 

Companies are breaking the silos, fostering cross-functional collaboration, implementing centralized regulatory operations, and harmonizing regulatory processes to drive cost efficiency and create opportunities for business transformation.

 

 

 

Trending
Opportunities & Challenges

Opportunities & Challenges

Opportunities & Challenges

The dynamic nature of regulatory guidelines has led to a greater need for knowledge-centric and intelligence-driven processes within the regulatory value chain.

To seamlessly address changing global regulatory requirements, drug manufacturers need to support their comprehensive regulatory domain understanding with a strong technology backbone. The industry is being pushed towards structured electronic documentation and submission management process as more agencies are adopting eCTD formats.  Regional regulatory requirements variations present a challenge in harmonization and content reusability. Implementing AI-based contextual automation can reduce documentation cycle time, simplify regulatory operations, and build structured assets for content reusability.

Service Framework

Pharma Regulatory Compliance
Service Assets
  • TEDREG - A global regulatory intelligence platform

  • An interdisciplinary team of regulatory SMEs & CMC experts

  • ePROOF: Automated label proofreading tool

  • Ecosystem: Alliances & partnerships

Differentiators

  • Embedded regulatory intelligence framework for proactive decision making and cross-functional knowledge sharing

  • Accelerated submissions through Robotic Process Automation (RPA) interventions and home-grown regulatory intelligence solutions

  • End-to-end regulatory service portfolio ensuring meticulous quality control and timely submissions

  • Standard SOPs & customizable templates along with multi-layered quality checks to increase the first-time-right quality

Benefits to the Customer

  • Increased speed to market by reducing submission preparation timelines using AI-based technologies

  • Integrated solution approach for greater cross-functional synchronization

  • Methods to minimize the cost of compliance and its impact on R&D investments

  • Centralized program management to foster collaboration between all the functions (Quality, Regulatory, R&D, etc.)

Discover More

Published 800+ pharma regulatory submissions for 70+ minor and major variations
Case Study

Published 800+ pharma regulatory submissions for 70+ minor and major variations

An agile, sustainable, and scalable lifecycle management operations for the regulatory function of a US-based pharma
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An agile, sustainable, and scalable lifecycle management operations for the regulatory function of a US-based pharma

4 things to know about Emergency Use Authorization in US and EU
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4 things to know about Emergency Use Authorization in US and EU

Pharmacovigilance Compliance - Changing Regulatory Landscape during Pandemic
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Pharmacovigilance Compliance - Changing Regulatory Landscape during Pandemic

50% cost reduction with blister packaging design
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50% cost reduction with blister packaging design

Clinical labeling documents as per regional guidelines
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Clinical labeling documents as per regional guidelines

The New Plain Language Labeling (PLL) Regulations by Health Canada
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The New Plain Language Labeling (PLL) Regulations by Health Canada

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