{"id":29,"date":"2019-03-22T12:45:34","date_gmt":"2019-03-22T12:45:34","guid":{"rendered":"http:\/\/excellpharma.com\/EPC\/?page_id=29"},"modified":"2019-06-13T12:29:29","modified_gmt":"2019-06-13T12:29:29","slug":"regulatory","status":"publish","type":"page","link":"http:\/\/excellpharma.com\/EPC\/regulatory\/","title":{"rendered":"Regulatory"},"content":{"rendered":"

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Regulatory Affairs<\/strong><\/h1>\n

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r<\/p>\n

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Our Regulatory Affairs capabilities is supported by the expertise of our consultants with years of hands on experience. Our goal is to bring practical, workable solutions to clients\u2019 regulatory problems or issues.
Our staff has assisted numerous clients in addressing and overcoming regulatory challenges. Below is a comprehensive list of project capabilities:<\/p>\n

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Regulatory Affairs<\/strong><\/h3>\n

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    \n
  • Preparation of NDAs, ANDAs, PMAs, and 510(k)s<\/li>\n
  • Development of Chemistry, Manufacturing and Controls (CMC) sections of regulatory submissions<\/li>\n
  • Act as Registered Agent for Foreign Manufacturer\u2019s of Products or APIs<\/li>\n
  • Preparation of Sterile Process Validation Packages (aseptic and terminal sterilization)<\/li>\n
  • Pre-submission review of drug and device submissions, sterile process validation packages, and documentation
    Electronic Submissions for FDA<\/li>\n
  • Comparability Protocol preparation for a variety of purposes, e.g., :\n
      \n
    • new or remodeled manufacturing lines<\/li>\n
    • changes to manufacturing sites<\/li>\n
    • changes to contract manufacturing sites<\/li>\n
    • changes in testing laboratories<\/li>\n
    • new or modified equipment<\/li>\n
    • new or remodeled aseptic areas<\/li>\n
    • alternative suppliers for components, active pharmaceutical ingredients, new manufacturing locations<\/li>\n
    • implementation of rapid microbiological methods<\/li>\n
    • implementation of process analytical technologies<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

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