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Consultant, Analytical Method Development and Validation

Ana Augusta Lemos

Graduated in Industrial Pharmacy (2005), postgraduate in Pharmaceutical Chemistry (2012) and Pharmaceutical Auditing (2013). With over 20 years of experience in pharmaceutical industries, both national and multinational, I have built a solid career in the area, working on Analytical Laboratory and Technical Documentation projects.

My work encompasses several areas, such as:

• Development and Validation of Analytical Methodologies
• Quality Control and Stability Studies
• Preparation of Protocols, Reports and Technical Justifications
• Validation of Cleaning Residuals and Gap Analysis
• Review of technical documents
• Support in response to regulatory requirements and specialized training

In the field of technical consultancy, I offer full support in the preparation of:

• Technical justifications for regulatory requirements
• Analytical Validation Protocols and Reports in accordance with RDC 166/2017
• Complete assessment (Gap Analysis) and forced stress studies
• Review of documents related to quality and change control

My passion is to disseminate knowledge and promote the exchange of experiences in the pharmaceutical area. If you wish to explore a specific topic or need technical support, I am available to talk and collaborate.

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