NAMSA professional medical regulatory consultants have substantial expertise of compiling and reviewing technical documentation and medicinal compound dossiers (the Widespread Technological Doc [CTD structure]) for drug/device products. This encounter ranges from wound dressings to coronary heart valves and drug coated stents.
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Create and disseminate evidence that solutions essential clinical, regulatory and business questions, enabling you to generate smarter decisions and meet your stakeholder requires with self-assurance.
With the outset of the 510(k) project, NAMSA’s professionals work with you to recognize by far the most appropriate predicate gadget(s), Together with conducting an Original hole Assessment of accessible info. This can help established the stage for what extra experiences, tests and information are going to be needed to provide you the very best prospect of An effective submission.
Our crew proficiently interprets that strategy into the appropriate documents for regulatory agency critique, including the following.
If you're previously an established organization, you might need help with recovering from non-compliance difficulties ensuing from an audit or help with building a completely new GMP facility. We may even provide back-fill team to include periods of absence or useful resource shortfalls on tasks.
Our group of over five hundred seasoned FDA, Wellbeing Canada and EU compliance consultants and regulatory affairs gurus can comprehend the complexities surrounding the pharmaceutical field plus the one of a kind inner workings of the regulatory method.
Christina Sanchez Miller, MPH has in excess of twenty years of management, biologics, high quality assurance and investigation expertise during the health care subject. She is a printed creator in scientific publications, papers and has introduced at several Worldwide conferences.
Led here by a team of tested GMP specialists, which have solved producing troubles like yours right before, all the things we do is in partnership with you and tailored on your exclusive wants and company objectives.
This text appears to be at The everyday job demands for pharmaceutical consultants and the kind of function frequently executed, together with case in point initiatives.
We’re at the rear of you—and constantly wanting forward. Aiding you move forward with confidence in a rapidly altering world wide natural environment. Remain resilient amidst at any time-shifting regulation. Switch essential options into your long-phrase gain.
More a short while ago now known as Pharmaceutical Excellent System (PQS), PharmOut delivers services and products in the form of Qualified technical writers and doc templates all targeted at offering and efficient and compliant QMS for your web site.
Our workforce can help build a regulatory tactic which will satisfy your requirements and timelines; we may handle the method from initiation by way of to completion. There are several other crucial Positive aspects:
All new products and appreciably modified legacy products inside the EU should be CE marked underneath the Professional medical Machine Regulation (MDR). Having said that, there remains to be numerous suppliers who maintain legitimate CE Marks beneath the MDD for legacy devices that ought to transition to MDR by May 2024; for realistic needs, suppliers need to post application for their NB by 2023, at the most recent.