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Optimizing Your Drug Patent Strategy: A Comprehensive Guide for Pharmaceutical Companies

Drug Patent Watch

Drug patents are a form of intellectual property protection that grants pharmaceutical companies exclusive rights to manufacture, sell, and profit from their innovations for a set period. This exclusivity is the lifeblood of the industry, allowing companies to recoup their substantial R&D investments and fund future discoveries.

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FOPE & PharmaState Academy hosts session 15 PULSE Program

Express Pharma

He explained the difference between incidents and deviations, stating that deviations are departures from written procedures, while incidents are unplanned events, reinforcing the need for clear SOPs and proper documentation. The session concluded with an interactive Q&A, and discussions that reinforced the key takeaways for participants.

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AI Act: data governance and compliance strategy implications in Pharma

European Pharmaceutical Review

The AI Act substantially raises the compliance bar for pharmaceutical companies using AI, particularly in high-risk applications. 2 This publication represents a critical step toward providing operational clarity and practical direction for pharmaceutical companies navigating this challenging regulatory environment.

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Gerresheimer enhances pharma packaging registration with comprehensive product database

Express Pharma

By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceutical companies. It contains revision dates, test results, certifications, and regulatory documentation.

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How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.

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7 common compliance issues faced by the pharmaceutical industry in India

Express Pharma

Here are seven key compliance challenges that Indian pharmaceutical companies often face: 1. Labour law compliance across states Pharmaceutical companies operate large plants and labs across multiple states, often employing a mix of permanent, temporary, and contract workers.

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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

Jayakumar also spoke about the detailed procedures and SOPs needed for investigating market complaints and how these systems should be integrated into a companys overall quality management system.