Gummies, effervescence, soft gels, tablets, capsules, small molecules, and pills. These are known as oral solid dosage (OSD) forms, which are final drug product therapies that are swallowed, dissolved in…
The pharmaceutical sector has been subject to intense competition over the past few decades, and this pressure has not decreased. New, more effective, and scalable operational models are becoming more…
What is the MDR (Medical Device Regulation) in Europe? For medical device firms that want to sell their products in the European market, compliance with the European Medical Device Regulation…
Introduction: The Annual Product Quality Review (APQR)/PQR stands as a pivotal regulatory requirement for pharmaceutical companies, mandated by the FDA and governed by cGMP guidelines. This annual review is imperative…
Background: Although numerous nations have their own set of laws, ISO 13485 is the primary Quality Management System (QMS) standard for medical devices. The QMS's scope can be customized for…
Introduction: Quality control and contract laboratories play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products. To uphold the highest standards, these laboratories must adhere to…
Introduction: A product can be systematically manufactured using a specific process that meets its predetermined specifications and quality attributes. This is known as validation. Established document evidence or proof offers…
Introduction: In the ever-evolving landscape of pharmaceuticals, the pursuit of more efficient and streamlined processes in drug product registration has led to significant advancements. At the forefront of this transformation…
Introduction: The journey to bring a medical device to market in the United States is a complex and highly regulated process that necessitates meticulous planning, thorough documentation, and adherence to…
Introduction: For several manufacturers of medical devices, access to international markets is crucial. As technology evolves quickly, obtaining marketing authorizations is essential, especially for new and novel devices. Gaining development…
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