Over the past 15 years, I have collaborated with international pharmaceutical companies from early (Phase I clinical trials) to late-stage development (Phase III clinical trials). Throughout my career, I supported numerous companies during national (IGJ) and international (EMA, FDA, Anvisa, TGA) agency inspections.
GMP READINESS SERVICE
Informed by years of experience in GMP readiness projects, I now offer my expertise as a consultant. My services include:
GMP Readiness Assessments
Evaluating your current practices to ensure they meet the required manufacturing standards.
Inspection Preparation
Guiding your team through the necessary steps to be well-prepared for inspections.
Compliance Strategy Development
Creating detailed strategies to maintain or enhance compliance with regulatory requirements.