Tag Archives: Clarify

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … finished. This letter may show one of three scenarios: -It may simply recognize that the inspection was done and that nothing significant was found. -It may list deficiencies found during the inspection, but may point out that no response is necessary.  Nevertheless, it is important that the site acts on these deficiencies in view of future inspections. -It may point out serious negative discoveries.  The site and the data are at risk here, and you must answer immediately to Clarify what steps …

  • Key Factors in Third Party Testing on Combination Products

    … one of their testing plants.  This ensures that both the government and the company itself cannot affect the testing, neither positively nor negatively, in any way.  This ensures a true unbiased assessment on the quality of the product. Sounds pretty simple, right?  Well, yes it does, in theory, but when it comes to testing combination products, things get a bit more complicated.  Let’s Clarify this.  Before the FDA tests a product, or takes the product to a third party testing …

  • Proposed FDA cGMP Regulations Impact Pharmaceutical and Biotech Industries

    … product has separate cGMP regulations. When products are combined together, confusion occurs as to which regulations apply to products when they are combined. These new OCP regulations concerning combination products would Clarify the following issues: •    Reduce confusion regarding cGMP requirements applied to combination products •    Ensure consistency with applications and enforce necessary requirements The biggest issue with combination products is when constituents are combined …

  • Creation of a Winning Business Plan

    … you progress towards your goals.  They can help you Clarify your key objectives, and solidify your marketing, operations, and management strategies. A good business plan has many elements.  It should first have a comprehensive overview of what you want to accomplish, your measurable deliverables, and your key defensible advantages.  This is particularly key, as you must be able to show investors that other companies have barriers to entry, and cannot simply copy your technology and beat you …

  • Surviving FDA Inspectors

    … timely manner will cause a good and professional impression. If you can’t find a specific record, never tell the inspector that it is unavailable; just tell him that you can’t locate it. Remember he’ll be checking your cGMPs, so handling every document request with care is also important. 5.    ATTEMPT TO Clarify OR CORRECT MISUNDERSTANDINGS OR ASSUMPTIONS: Never guess what the inspector is thinking. If you encourage him to discuss his observations at the moment they are performed, …

  • How To Get Ready For a Merger Or Acquisition

    … Negotiate for a win/win situation.  The specialist will be there to assist you and help you avoid disputes.  His or her objective view will help you sort the toughest issues. The specialist may also help your potential buyer find financing opportunities. Many owners finance part of the price to their buyers. Define terms and conditions early on.  Clarify if the buyer will limit your future participation in the field, if you will work for them in any way, or if you are keeping some assets. …