BioTeknica, Principal & Co-Founder Affiliate
Braulio is an expert in the areas of quality assurance, engineering, and manufacturing in the biomedical, pharmaceutical, and medical device industries. His 25+ years of experience includes quality systems improvement strategies, Six Sigma, Business Process Re-Engineering, facilities commissioning, validation, and cost reduction initiatives. He has vast experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well as successfully addressing FDA inspections, Consent Decree and Warning Letter responses. He has his MBA from University of Miami and his BS in Chemical Engineering from Cornell University.
BioTeknica is a consulting firm specializing in engineering, quality and regulatory projects for the Medical Device, Biologics and Pharmaceutical industries. They have a solid track record of providing resolution for FDA compliance and validation issues. Their services include Engineering, FDA Inspection Readiness, Regulatory Compliance, Validation and IS/IT Systems Management.