Along with developing validation documentation and standard operating procedures we also offer guidance in all facets of validation in order to help our customers achieve regulatory success.  We also understand that our clients have put valuable time and monies into developing their Quality Systems so we ensure we follow them to the fullest while still maintaining FDA compliance.

You can expect the following:

• Utilizing our customer's Quality System, when in place, while developing protocols and procedures
  Flexibility in the writing process

• We can utilize our own protocols / procedures

• We are willing to utilize templates created by our customers

• We are capable of assessing Original Equipment Manufacturer's Protocols (OEMs) and developing wrapper 
  protocols to meet your Quality System requirements

• A list of all regulations consulted or referenced in regards to our guidance