Providing professional consulting and training
services to the pharmaceutical industry both domestically and Internationally.
Have your audit conducted as if FDA were in your facility. No project is too small.
Services include:
Mock audits
Gap
assessments
Specialized training which
includes a three day course for your audit team conducted by ex-FDA investigator/pre-approval manager and chemist.
Annual GMP training along with training involved in committments
to warning letter responses.
Your
quality group requires auditing and we can help in that area when needed.
Have your NDA/ANDA CMC reviewed by ex-FDA pre-approval manager and chemist BEFORE you file.
In addition, services include the review of investigation/deviation/non-conformance and OOS reports as if
FDA were reviewing them during an inspection. Have your report reviewed prior to the regulatory inspection. Questions
and comments will be posed as if FDA were looking at the reports. Your reports should be stand alone documents and the
review will help you maintain the appropriate criteria for report writing for the regulatory audience.