Allison C. Komiyama, Ph.D., R.A.C.

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Owner and Principal Consultant

Allison is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. She started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. She received her Regulatory Affairs Certification (US) in 2014.

While working at FDA as a biologist and reviewer in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510(k) Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs in support of FDA recognized ISO and ASTM standards.  After her time at FDA, she worked as a project manager and regulatory affairs manager at an in vitro diagnostic device company, as well as a senior regulatory specialist and director of regulatory affairs at two consulting firms.  

Allison has worked with clients from all around the world whose companies range from small 2 person startups to large firms with over 40,000 employees. She has worked on a diverse assortment of devices, including orthopedic devices (spine, hip, knee, and other skeletal  implants), bone void fillers, general hospital devices, urological devices, dental implants, in vitro diagnostic devices, wearable technology, combination products, mobile medical applications and neuro-stimulating devices. 


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Lucie Dalet, Ph.D. 

Regulatory Specialist

Lucie received her Ph.D. in Neurobiology from the University of Montpellier, France. She moved to San Diego in 2013 to continue with research at UCSD. During her time in academia she developed her scientific writing and project management skills, focusing on gene therapy for a genetic disease of the eye, spinal cord injuries, and peripheral nerve injury. 

After almost a decade in academic research, Lucie decided to explore a transition to industry and Regulatory Affairs. She is a member of the San Diego Regulatory Affairs Network, which is how she learned about AcKnowledge. As a Regulatory Specialist for AcKnowledge, she helps with all things regulatory, from authoring submissions, overall regulatory strategy, and ensuring client compliance with FDA recognized standards.


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Pierre Bounaud, Ph.D. 

Senior Regulatory Specialist

Pierre received his B.S. in Chemistry and Chemical Engineering in Lyon, France and then his Ph.D. in Chemistry from State University of New York at Stony Brook. He moved to San Diego to study natural product synthesis at The Scripps Research Institute in La Jolla, CA, before shifting to the biotech industry. He has over 15 years experience as a drug discovery scientist, focusing on several therapeutic areas such as oncology, antibacterials, and Parkinson's disease.

Before joining the regulatory team at AcKnowledge, Pierre received his training on EU regulations for medical devices at a consulting firm specializing in international regulatory compliance. His expertise includes CE marking for medical devices, EU technical files, and medical device usability. As a Senior Regulatory Specialist for AcKnowledge, he helps with US and EU regulatory files, regulatory strategy, and combination product submissions.


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Aarthi Karkal, M.S.

Regulatory Specialist

Aarthi received her Master’s degree in Cell and Molecular Biology from the University of Houston. She subsequently worked as a research assistant at Baylor College of Medicine, where she developed transgenic mouse models of cardiovascular disease. While in academia, Aarthi honed her written and verbal communication skills by authoring publications, presenting original research at scientific meetings, and teaching students.

Keen to transition to regulatory affairs after a decade in academic research, Aarthi completed the University of California, San Diego regulatory affairs certificate program. She is an active member of the San Diego Regulatory Affairs Network, and joins AcKnowledge-RS as a regulatory specialist. In her role, Aarthi will author submissions, help clients develop their regulatory strategy, and ensure client compliance with FDA standards.


Erin A. Gontang, Ph.D.

Project Manager and Technical Writer

Erin received her Ph.D. in Microbiology from the University of California, San Diego, and her B.A. in Molecular and Cellular Biology from the University of California, Berkeley. She also spent four years as an NIH-funded postdoctoral research fellow at Harvard Medical School, in the Department of Microbiology and Immunobiology.

Erin has spent years talking and writing about science and technology. Her experience as a science writer for eLife Sciences Publications, Ltd. has helped hone her writing skills and her ability to explain cutting-edge research to a diverse audience. Erin is an active member of the American Medical Writers Association, and has been an active member of and event coordinator for the Association for Women in Science.

As Project Manager and Technical Writer, Erin reviews complete submissions for consistency with FDA standards, updates documents for regulatory submissions, helps maintain onsite and electronic archives, and otherwise lends her knowledge and expertise in all pursuits. 


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Blythe Sinclair

Administrative Assistant

Blythe is a freshly-graduated student who received her B.A. in English with an emphasis in Creative Writing from St. Mary’s College of California in May 2018. Despite being a Biology major for the first year and a half of her college career, she completed all of her college classes one semester early, and moved back to San Diego in December 2017 to begin working. During her time at St. Mary’s College, she developed her diverse writing portfolio, became published in the college’s literary magazine, and traveled to Cork, Ireland for one month to participate in a course dedicated to the arts, where she showcased her work alongside local artists.

Blythe currently works for AcKnowledge as an Administrative Assistant. In her role at AcKnowledge, Blythe completes numerous tasks, including website and office management, correspondence with clients, and aiding with FDA regulatory submissions.


Caitlin Hannah

Marketer and Business Manager

Caitlin is a marketer by trade who helps AcKnowledge with anything that needs to be written, marketed, or shared on social media. She collaborates with Allison on the AcKnowledge blog, LinkedIn posts, and Twitter feed. Caitlin received her B.A. in Spanish from Northeastern University and after working in customer service and account management, went on to pursue a career in marketing. After spending 6 years in marketing at The National Geographic Society in Washington, D.C., she moved to San Diego and started her own marketing and copywriting business.

Her experience with a variety of industries, including microelectronic chemicals, birth and natal care, brain injury care and education, medicare reimbursement, and medical devices, means that she is adept at relaying complex information to a range of audiences. She finds little more exciting than sharing important, life-changing work with the world.

 

Banner photo by Phalinn Ooi. Headshots by Nicholas Andrews.


Interested in joining our team?  Click HERE for career opportunities with AcKnowledge RS!