Kategorije za Uncategorized

ePI subject matter expert

ePI subject matter expert: why pharma companies should not choose an ePI vendor without strategic guidance

June 3, 2026 9:44 am Published by

Pharmaceutical companies across Europe are increasingly searching for answers to the question: “which vendors support structured product labeling to ePI?” But most organizations are already approaching the problem from the wrong angle. The real challenge is not finding software. The real challenge is surviving the operational complexity that comes with ePI implementation — a challenge... View Article

batch release certificate

Who offers end-to-end and batch release certificate services?

June 2, 2026 8:09 am Published by

Pharmaceutical companies entering the European market often initially struggle to identify a suitably qualified Qualified Person (QP). However, the real challenge begins when they must simultaneously coordinate documentation, importation, GMP compliance, audit readiness, product release timelines, and ongoing GMP consulting support across multiple stakeholders.  In many cases, the process behind obtaining a batch release certificate... View Article

ePI readiness

ePI project timeline and cost estimates: how to achieve ePI readiness before regulatory deadlines

May 28, 2026 11:47 am Published by

Many pharmaceutical companies are underestimating how difficult achieving ePI readiness will become once implementation deadlines move closer. What initially appears to be a straightforward compliance initiative often turns into a complex transformation involving regulatory workflows, structured content authoring based on HL7 FHIR standards, multilingual labeling, IT system integration, governance, and lifecycle management. Without a realistic... View Article

qp batch release

QP batch release solutions for pharmaceutical companies entering the EU market

May 26, 2026 2:12 pm Published by

Pharmaceutical companies expanding into Europe often underestimate the complexity of QP batch release once products enter the EU regulatory framework. Under EU GMP Annex 16, every medicinal product batch released to the European market must be certified by a Qualified Person before distribution can legally occur. This requirement applies regardless of whether the product is... View Article

medical device regulatory consultant

Medical device regulatory consultant for PRRC and MDR compliance

May 22, 2026 9:23 am Published by

If you are looking for a medical device regulatory consultant, the situation is usually already serious. Deadlines are approaching, MDR requirements keep expanding, notified body expectations are becoming harder to interpret, and your internal teams are struggling to keep regulatory documentation, vigilance obligations, PRRC responsibilities, and quality systems fully aligned. What initially looked manageable often... View Article

QMS consulting

Experts for Quality Management System Remediation: why companies need QMS consulting

May 21, 2026 1:55 pm Published by

Companies operating in pharma, medical devices, and other regulated industries cannot afford a weak quality system. Regulatory authorities emphasize that companies must maintain robust and sustainable quality systems to ensure continuous GMP compliance and inspection readiness. When deviations, audit findings, missing documentation, CAPA failures, or inspection observations begin to accumulate, the entire business is at... View Article

electronic product information vendor

Recommended tools for structured product labeling updates: why ePI consultancy matters before choosing an electronic product information vendor

May 21, 2026 12:09 pm Published by

Pharmaceutical companies are under increasing pressure to modernize labeling processes and prepare for electronic product information (ePI) requirements. Yet many organizations searching for “recommended tools for structured product labeling updates” quickly discover that selecting the wrong platform can create costly implementation delays, fragmented workflows, compliance risks, and long-term operational inefficiencies. The challenge is no longer... View Article

Repurposing of drug

Repurposing of drug: the overlooked opportunity pharmaceutical companies can no longer ignore

May 15, 2026 12:34 pm Published by

Pharmaceutical companies today are surrounded by data—clinical results, safety signals, real-world evidence—yet some of the most valuable opportunities remain hidden in plain sight. Statins are a striking example. For decades, observations of anti-inflammatory and immune-modulating effects were logged as secondary findings and largely set aside. Today, those same signals are driving serious research into statins’... View Article

ePI requirements

ePI requirements: what pharma companies must do now to stay compliant under the new EU legislation

May 15, 2026 9:40 am Published by

Pharma companies across the EU are facing a growing pressure that many still underestimate. The shift toward ePI requirements is not just another regulatory update, but a fundamental change in how product information must be created, managed and delivered. Under the new legislation, structured electronic product information is becoming a formal requirement, replacing static documents... View Article

ISO 13485 risk management

ISO 13485 risk management that passes audits and accelerates your medical device approval

May 8, 2026 10:36 am Published by

If you are looking for ISO 13485 risk management checklist for medical devices, you are likely not at the beginning—you are already facing pressure. On paper, ISO 13485 risk management seems straightforward: define risks, document them, and demonstrate control. But in practice, it quickly becomes one of the most difficult parts of your entire quality... View Article