Review, analysis, development and translation of the documentation during the GMP inspection stages (package of documents to submit the inspection request, package of documents for the CAPA materials, a documentary justification related to the questions arised during the inspection). Preparation of the necessary documents for submitting the inspection request. Analysis of the non-conformities detected during the inspection, development and proposal of the possible CAPA plans at the manufacturer's choice. 
Detailed development and preparation of the CAPA materials package. Study of the CAPA materials, developed by the manufacturer in order to evaluate its sufficiency and eliminate previously detected non-conformities, recommendations for necessary corrections. Preparation of the appropriate professional justifications for the "controversial issues" detected during a previous inspection or audit with reference to the scientific sources and the regulatory framework.
Advice on compliance with GMP standards for successful inspection. Advice on all questions from manufacturers in the field of good manufacturing practices.