Happy New Year from EMMA International! Your ‘one stop shop’ for all your quality, regulatory, and compliance needs. The new year brings with it the halo of fresh starts and new opportunities. What hasn’t changed are the usual constraints of time, budgets, and people. Position your thinking...
Spring is off to a great start for E.M.M.A. International! We are beginning this spring season by offering a new, unique service to those looking to find direction for their quality and regulatory needs. If you’re not sure where you stand with a project, your...
This is the time of year when many of us tend to retake stock of our homes and lives – we clear the cobwebs, file our taxes, plan our vacations, and generally organize ourselves. So, too, should we reevaluate and organize our company’s status pertaining...
A need to have an effective and modern approach for a pharmaceutical Quality Management System (QMS) resulted in the International Conference on Harmonization (ICH) developing a new quality system guidance that has the ability to support the regulatory framework for the pharmaceutical industry. It is...
In the past, FDA’s guidance on post approval changes made to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Chemistry Manufacturing and Controls (CMC) has been ambiguous and hindered continuous improvement of pharmaceutical manufacturing processes. NDA and ANDA holders are expected to perform...
Since its creation in 2002, the Office of Combination Products (OCP) has been tasked with developing regulations and guidance documents for combination products [1]. A combination product is a product composed of any combination of drug/device, drug/biologic, biologic/device, or device/drug/biologic [2]. The three types of...