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As and ex-FDA Investigator, I will add that Kevin's advice is spot on. The affidavit is essentially a document attesting to the truth/accuracy of some situation be it simply an affidavit that has you attesting to the accuracy of certain documentation the Investigator has collected, or an admission of ...

Let me preface my answer here by saying I'm a "drug" guy, not a "device" guy. That said, I'm the US Agent for several firms on the drug side and the requirement is simply that an agent has be someone based in the US. Frankly, I believe this is all fairly out-of-date given our ability to communicate globally ...

I'm looking for someone with particular expertise in the area of Canadian customs laws and regulations regarding the import of an API into Canada from Germany. Christopher Smith, CQE, RAC President, Coastal Pharmaceutical Consultants, Inc. 7950 Old River Road, Burgaw, NC 28425 USA +1-910-789-1232 ...

Hi Vicki, I have used Global Apostille Services in the past and found them very knowledgeable and helpful.  Chris ------------------------------ Christopher Smith, CQE, RAC Coastal Pharmaceutical Consultants, Inc. 7950 Old River Road Burgaw, NC 28425, USA 910.789.1232 (mobile) chrissmith@c ...

I'm looking for recommendations for RA/QA consultants who are specifically familiar with and well-versed in the FDA regulations and requirements for compounding pharmacies and who may be able to assist in an evaluation of a compounding pharmacy group's current state of compliance.  Any suggestions or ...