Staying ahead in Environmental, Health, Safety, and Quality (EHSQ) management means balancing compliance, employee engagement, and operational efficiency all while navigating an ever-changing regulatory landscape. That’s no small task for any organization.  Intelex’s latest updates are designed to make staying current easier. From better functionality to smarter, more intuitive tools, these improvements help organizations gain […]

In the pharmaceutical world, quality is non-negotiable. It’s what keeps patients safe, regulators satisfied, and operations running smoothly. But here’s something we don’t talk about enough: quality isn’t just about the product; it’s also about the systems that support it.  Getting the Quality Management System (QMS) or any other critical application implemented is a major […]

Global health authorities are increasingly shifting their regulatory frameworks toward structured submissions, a move that’s reshaping how life sciences organizations manage labeling, CMC, and regulatory content. In Canada, Health Canada has formally signaled this transition by mandating the use of XML-formatted Structured Product Monographs (XML/SPM). Health Canada’s adoption of XML/SPM submissions is a major step […]

The rapid evolution of artificial intelligence is transforming every industry, and software development is no exception. AI tools are helping teams move quickly and automate previously complex tasks at an unprecedented pace. With this shift, the old model of relying heavily on manual testing is no longer sustainable. Automated testing has become a fundamental requirement […]

Environmental, Health, and Safety, and Quality (EHSQ) compliance is no longer just a legal requirement, it’s a strategic imperative. EHSQ encompasses the policies and practices that keep workplaces safe, protect the environment, ensure product and process quality, and manage operational risk. Businesses are increasingly expected to demonstrate corporate responsibility, from addressing climate change and ESH […]

Pharmaceutical companies are facing mounting pressure to streamline their global labeling operations, which can be a risky and costly full-scale transformation. A targeted pilot provides a strategic, low-risk way to uncover current state gaps. Most importantly, it validates how emerging technologies like component-based authoring and generative AI can close those gaps. By offering stakeholders clear […]

The pace of regulatory change in life sciences is accelerating, and few areas reflect that more clearly than oncology. Project Orbis, an initiative led by the FDA’s Oncology Center of Excellence, offers a real-time case study in how regulatory content submission and generation are evolving. For this discussion, we spoke with a seasoned global labeling […]

Pharmaceutical companies are constantly adapting and evolving their systems to keep up with new regulatory requirements. But modernization isn’t always easy, and it must be done without disrupting quality, efficiency, and most importantly, compliance. In a highly regulated industry like pharma, it’s essential to carefully plan each change.  There is a delicate balance between enhancing […]

As health authorities around the world move steadily toward structured labeling standards like electronic Product Information (ePI), Pharma Ledger, and Structured Product Monograph (SPM), mid-to-large-sized pharmaceutical companies are asking a critical question: How do we support global requirements without overextending our internal teams or making irreversible investments? For many, the answer is to partner with […]

Pharmaceutical organizations, whether global giants or mid-sized companies, are facing a regulatory wave. With the Jordan Food and Drug Administration (JFDA) mandating the submission of electronic product information (ePI) in the Fast Healthcare Interoperability Resources (FHIR) format, the European Medicine Agency (EMA) wrapping up its successful FHIR pilot program, and a growing number of countries […]