Preparation of FDA Process Filing Documents and Responses to FDA Inquiries and Inspectional Observations:

As your Process Authority Partner, IEH can assist you with the preparation of the required FDA process filing documents and the required support documentation for those filings. If your filings have been returned with requests for additional information, we can assist with the preparation of the responses and interact with the agency on your behalf. Similarly, if one of your plants has been inspected, or if an inspection is in progress and problems arise, we can, as your process authority, advise and assist in preparing responses to the agency.