Do you know when to use the FDA Pre-Submission Program?
You just designed the greatest, cure-all class II medical device of all time! Terrific! Now what? Just go to the FDA website, follow the step-by-step procedures for submitting a “traditional” 510(k),...
View ArticleDo I Need a Medical Device Consultant to Review My Quality Management System...
What is a Quality Management System (QMS)? As a marketer or manufacturer of medical devices, you know that a quality management system (QMS) is critical to your success and continued operation. It...
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With FDA Combination Products on the Rise, a Common Question is, “Which...
What is a Combination Product? In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of...
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Seven Noteworthy 505(b)(2) Submissions
As drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross...
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Pharmacokinetics in Drug Development Related to ANDA/505(b)(2) Submissions
As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the...
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