Pharma software and solutions for comprehensive compliance excellence
Showcase your commitment to quality by providing the highest standards of safety and efficacy.
Intro
Inspire confidence and trust
Quality management in pharmaceuticals is of paramount importance to ensure the safety, efficacy and reliability of drugs. Missteps can lead to severe health risks, making quality management an integral part of pharmaceutical production.
By adhering to quality management principles, you not only comply with legal requirements but also build trust with clients and patients who rely on your products for their health and well-being.
Key Challenges
Understanding the key challenges in pharma
We support leading pharmaceutical companies through their compliance journey and help ensure the health and safety of their customers.
- Research and development costs - Developing new drugs is a time consuming and expensive process. From the initial planning to launching a new product on the market, it requires rigorous tests and extensive documentation
- Regulatory landscape - The pharma industry is highly regulated to ensure the safety and efficacy of drugs. Navigating complex and evolving regulatory frameworks is a significant challenge
- Talent shortages - Employee shortages can hinder drug development, slow down innovation and increase operational costs. It creates the risk for errors and additional delays in bringing new medication to market
- Reputational damage - ven a small scandal can lead to the loss of trust amongst your customers and can have far-reaching consequences including harming stakeholder relationships, and affecting market value
Improve accuracy and data integrity
Identify and mitigate risks that can slow down the drug approval process. Reduce the chances of adverse events and preserve both the company's reputation and patient safety.
Ensure regulatory compliance
Ensure that products meet rigorous safety and quality standards, reducing the risk of compliance issues and potential legal consequences.
Documentation and record-keeping
Ensure traceability, transparency, and accountability in all phases of drug development, production, and distribution, aiding in regulatory submissions and audits.
Competency management and collaboration
The right teamwork is essential for ensuring the successful development, production, and distribution of safe and effective medications.
Q-Pulse plays a critical part in Roslin Cells' compliance requirements
Roslin Cells had previously been using a paper-based system to manage their quality processes. Due to expansion and prospective growth, it was quickly realised that their previous methods were time consuming, unpractical and extremely labour intensive.
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Industry solutions
Quality management
Comply with industry standards and regulations whilst reducing quality and compliance risks. Ensure products meet vital specifications and standards, fostering a culture of quality control and ensuring customer satisfaction.
Streamlining quality processes and enhancing compliance
Roslin Cells, a world leader in delivering clinical grade stem cells, faced challenges in managing their quality processes and compliance with strict GMP regulations. With Ideagen, Roslin Cells streamlined their quality management, reduced paperwork and improved compliance with multiple regulatory bodies.
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Homerton Fertility Centre: Perfecting the pathway to HFEA accreditation
Homerton fertility centre achieve HFEA accreditation with Q-Pulse. Find out more.
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Four of the top five CROs select Ideagen PleaseReview to accelerate timelines
Ideagen PleaseReview has been selected by four of the top five global CROs to support the delivery of faster and more efficient clinical trials to sponsors. Find out more.
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Lexicon Pharmaceuticals saves hundreds of hours by reducing document review times
With over 200 employees and multiple drug programs, the need for a streamlined review process was critical. Ideagen PleaseReview enabled real-time collaboration and reduced the time spent on reviews drastically.
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Understanding ICH Q7, Q8, Q9 & Q10: Guide for pharma quality
Learn the differences between ICH Q7, Q8, Q9 & Q10 guidelines. Discover how these crucial documents impact pharmaceutical quality, safety and compliance
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ICH Q9 Quality Risk Management: Guide for the pharma industry
Understand the importance of ICH Q9 in ensuring pharmaceutical product quality and patient safety. Learn about risk assessment, control, and communication.
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Why data quality matters in the pharmaceutical industry
Learn about data integrity, regulatory requirements, advanced technologies and best practices to enhance compliance and operational efficiency.
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Quality assurance plan for pharmaceutical companies
Download our free white paper & discover best practices, cutting-edge tech, & practical tools to elevate compliance, optimize operations & achieve excellen
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