Dr. Steffen Engel

Owner

About 20 years of experience in the pharmaceutical industry

Having worked in Germany, the United States, and Brazil in functions of
Pharmaceutical Operations - Quality Control, Production, Company Headquarter, and Quality ManagementProven expertise in processes around Production and Quality Management Systems of small molecule solid/liquid oral dosage forms and Inhalation

Quality Management Systems:
General quality systems, FDA, EMA, ANVISA Regulation
Quality Risk Analysis and Risk Management, Investigation, Deviation, CAPA, Change management
Remediation of audit observations, 483, warning letters
Quality control and analytical development laboratories
Operational Excellence:
Review and optimization of all relevant business processes
​Process analysis and optimization with many tools (FMEA, SIPOC, DMAIC, 5S, etc.)
Creation and implementation of metric systems and monitoring of performance
Management reporting systems

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About Us

Helping business owners to strengthen a solid foundation and business strategy so they can be successful. Support in knowing the requirements to improve compliance, processes, productivity, strategy, and company culture to grow and develop the organization.

Services can be provided in English, German, and Portuguese.

MISSION

TO IMPROVE YOUR PERFORMANCE,
Drive results and Create Value for the growth of your BUSINESS