The Biotech Box

“My company is the sponsor of a pivotal Phase III clinical trial, and we hired Cinta to help us prepare for an FDA GCP audit. Cinta conducted a mock FDA audit for our team and also for our CRO that was thorough, professional, and instructive. Cinta found the weak spots in our preparedness and gave us excellent coaching in terms of readiness for an audit and conduct during a real audit. I highly recommend her work.”

“Cinta was a valued quality consultant at Boston Scientific, during our project to build and implement a GLP compliant laboratory. Her approach was extremely professional and her broad quality and engineering experience was a huge asset to the BSC team. I highly recommend Cinta, and would welcome the opportunity to work with her in the future.”

“I had the opportunity to work with Cinta in a small company setting where we were responsible for a series of challenging GLP and GMP assays. She was able to set priorities and create order in high-pressure, chaotic situations in order to achieve team deliverables. She also provided highly valued leadership in aspects such as training, continuous improvement and client audits. Her excellent communication and interpersonal skills allowed her to be an essential resource for entry-level analysts and industry veterans alike. I definitely recommend Cinta for any organization seeking an experienced, highly engaged quality professional and leader”

“Cinta helped our firm through the initial months of a quality system harmonization when we recently acquired another facility working under GMP/GLP requirements. Throughout the transition Cinta provided excellent support, guidance, and advice on the most appropriate manner in which to prioritize and harmonize the quality system attributes. During the time we worked together I found Cinta to be very professional and extremely knowledgeable regarding GMP and GLP systems. Most importantly she approached the project with a very logical, risk-based approach toward phase appropriate requirements of a GMP system within a research and development environment. I would highly recommend working with Cinta based on our very positive experience."

“As the head of Quality Assurance, Cintas’s work was tremendous. She set up a phase-appropriate Quality System, emphasizing regulatory compliant production of safe and effective product while taking into account our resources and strict timelines. Her style, personality and “people skills” are ideally suited to the small and mid-stage biotech environment. We were sad to see her leave, but when it came time for us to bring on a full-time Senior Director of Quality Assurance, Cinta eagerly jumped in to help find the right person and facilitated their transition into FDL. I would readily work with Cinta again in the future; she would be an asset to any company needing to initiate the regulatory Quality Assurance function.”

“I worked with Cinta on implementing a new electronic Quality Management System (eQMS) and on creating new and improving existing Quality Systems. It was a pleasure to work with Cinta and I learned a great deal from her. She has a wealth of knowledge she is always ready to share and you can always count on her to find a solution to a problem and to stay calm and focused during a crisis or meeting a tight deadline. I highly recommend Cinta and would enjoy working with her again in the future.”

“I have worked with Cinta on several QA projects over the past few years; she is very knowledgeable and possesses strong leadership and interpersonal skills. I always enjoy working with Cinta."