• A 501c3 not for profit corporation (formerly High Alert International)• Dedicated to empowering individuals, families, communities, businesses and organizations to be disaster ready• Provide NIMS-compliant training and educational programs to serve the needs of both professional and volunteer disaster responders, as well as citizens and communities seeking to plan and prepare for any type of disaster or serious event

Medical & Regulatory Affairs Specialists, LLC is a full service Regulatory Consulting business with the key objective of providing high quality services to the global Biomedical Device industry. Founded by a research physician, nurse and engineer, MRAS understands and applies international regulatory and quality standards throughout their work. Through the effective use of an international network of resources, MRAS ensures timely deliverables that meet the multitude of international standards.MRAS provides a valuable pool of experience and resource for concise, effective, scientifically supported communication between biomedical device industry innovators, governmental regulators, notifying bodies and the myriad of short term consultants necessary to support a successful application for biomedical device approval. Services include:• Provide literature reviews, statistical analysis, editorial review, medical, and clinical trial consult services to biomedical and medical device firms: early-stage and Fortune 500• Prepare Clinical Evaluation Reports in compliance with MEDDEV 2.7.1 Rev3 for endovascular device CE mark submissions• Conduct clinical data audits, including query generation and resolution• Perform safety and efficacy data integrity audits and analyses for FDA submissions, as well as medical journal publication• Ensure clinical and regulatory compliance to Good Clinical Practices (GCPs) and International Conference on Harmonisation (ICH) requirements• Assist with PMA and IDE submissions and supplements• Provide literature review, statistical analyses and editorial services for biomedical device Humanitarian Use Device (HUD), Pre-Market Approval (PMA) and FDA 510k submissions and responses

• A women and minority owned business• Parent company of three enterprises: o Medical & Regulatory Affairs Specialists, LLC o Natural Air E-Controls, LLC o High Alert International (subsumed by High Alert Institute, Inc.)

The Natural Air E-Controls, LLC is registered as a limited-liability corporation registered in the State of Florida (doc. #L16000083898) . Our four founders, Allison Sakara, Mike Bivins, Jonathan Carson, and William Carson, Jr., are equal managing members/voting co-owners through their individual privately held Limited Liability Companies. Two of our inventors are non-voting regular member-investors under a SAFE Agreement (Simple Agreement for Future Equity) in exchange for their intellectual property and other valuable considerations. No outside investors are involved at this point in time, however our 2019 growth plans include finding a private (angel, venture or friend/family) investor and making a Regulation Crowd Funding offering in 2019.

Regulatory Affairs• Provide literature reviews, statistical analysis, medical, and clinical trial consult services to biomedical and medical device firms: early-stage and Fortune 500• Prepare Clinical Evaluation Reports in compliance with MEDDEV 2.7.1 Rev3 for endovascular device CE mark submissions• Conduct clinical data audits, including query generation and resolution• Perform safety and efficacy data integrity audits and analyses for FDA submissions, as well as medical journal publication• Ensure clinical and regulatory compliance to Good Clinical Practices (GCPs) and International Conference on Harmonisation (ICH) requirements• Assist with PMA and IDE submissions and supplements• Provide literature review and statistical analyses for neurovascular Humanitarian Use Device submissions and responses• Member of team responsible for regulatory compliance with opening of new device manufacturing facility• Develop Case Report Forms • Recent project industry sponsorsClinical Research• 28 years of experience in nursing• 20+ years as a nurse practitioner• 10+ years in disaster medicine• Hands-on medical assessment and treatment of clinical trial subjects as a co-investigator in large, urban, university-based centers of excellenceo Daily medical assessment and management of subjectso Data collection and data entry o IRB submissions of government and industry-sponsored protocolso Maintained compliance and communications with local IRB regulations• Governmental clinical trial sponsorso NIH (National Institutes of Health)o CDC (Centers for Disease Control and Prevention)o HHS (Department of Health and Human Services)o HRSA (Health Resources and Services)o NHLBI (National Heart, Lung, and Blood Institute)National Healthcare Policy Experience• Health Security Policy Pilot Work Group member• ASPH (Association of Schools of Public Health) Development Committee memberHospital Committee Experience• Pain Management • Pandemic Preparedness

Pennsylvania-1 Disaster Medical Assistance Team (PA-1 DMAT): Pittsburgh, PASupervisory Nurse Specialist (GS-13); CRNP; Extended Command Staff• Provide direct medical care to civilians and disaster/recovery workers in the wake of a federally declared disaster/mass casualty incident and to military casualties evacuated from an area of conflict• Supervise mid-level, RN, paramedic, EMT, and logistical staff as Strike Team leader or Section Care Provider (typically Critical Care)• Extensive field experience in response to hurricanes Charlie, Frances, Ivan, Jean (2004); Katrina, Rita, Wilma (2005-2006); Gustav, Ike (2008)• Member, PA-1 DMAT Training Committee – provide training, education, competence evaluation, and assist in coordinating large scale drill sessions for disaster scenarios and mass casualty events

(Company subsumed into High Alert Institute, Inc a 501c3 not-for-profit corporation)• Disaster Preparedness, Mitigation, and Recovery consulting firm serving medical, business, and educational communities• Professional speaker, author, and grant writer for disaster preparedness, disaster nursing, and support of 18 Critical Infrastructure/Key Resource industries• Technical consultant for Spike TV's "Surviving Disaster" and “1,000 Ways to Die”• Respondent to Haiti Earthquake, Telemedicine Section Chief

Pennsylvania-1 Disaster Medical Assistance Team (PA-1 DMAT): Pittsburgh, PASupervisory Nurse Specialist (GS-13); CRNP; Extended Command Staff• Provide direct medical care to civilians and disaster/recovery workers in the wake of a federally declared disaster/mass casualty incident and to military casualties evacuated from an area of conflict• Supervise mid-level, RN, paramedic, EMT, and logistical staff as Strike Team leader or Section Care Provider (typically Critical Care)• Extensive field experience in response to hurricanes Charlie, Frances, Ivan, Jean (2004); Katrina, Rita, Wilma (2005-2006); Gustav, Ike (2008)• Member, PA-1 DMAT Training Committee – provide training, education, competence evaluation, and assist in coordinating large scale drill sessions for disaster scenarios and mass casualty events

In-Patient/ER Sickle Cell Nurse Practitioner• Provided first-line medical management of all patients with sickle cell disease in the Emergency Room, ICU, and In-Patient settings• Developed and maintained Individualized Pain Management Plans for all patients with sickle cell disease followed by the Center• Assisted attending physician with writing and submission of HRSA grants, IRB proposals, data collection, data entry, and writing of abstracts pertaining to on-going research studies at the Center for patients with sickle cell disease• Shared weekend on-call duties and coverage of vacant positions within the division, providing first-line medical management of all patients followed by the Hematology/Oncology/BMT service)• Precepted medical, nursing, and genetic counseling students (undergraduate and graduate levels)• Provided in-service education to and served as a resource for all hospital staff re: sickle cell disease, hemoglobinopathies, and newborn screening • Served as resource to regional healthcare professionals, school personnel, and community agencies on sickle cell disease and the medical management of patients with sickle cell disease• Member of the following hospital Committees:o Pandemic Influenza Preparedness o Disaster Credentialing Standards o Pain ManagementEducation Specialist, 8 South (Adolescent Medicine Unit)• Provided unit-based training, education, and competency assessments for RNs and support staff for this Unit dedicated to the care of Hem/Onc, Diabetes, and Cystic Fibrosis patients• Assisted in development of departmental programs and strategies to enhance the knowledge base of pediatric nurses and support staff• Represented the needs and concerns of the unit staff in both departmental and multidisciplinary meetings and committees

Transport Nurse, Critical Care Team• Provided and managed the care of critically and seriously ill patients (adults and children) during inter-facility transport• Coordinated with crew to ensure the highest level of care possible• On-board services included but were not limited to the following: internal or external pacing; ACLS interventions; cardiac monitoring; maintaining ventilations via Uni-Vent portable ventilator; infusion of blood products, TPN, and medications typically used in an ICU

• Developed and implemented regulatory strategies and processes to assure timely global commercialization of products in compliance with the laws and regulations provided by governments and regulating agencies• Prepared IDE/510K and PMA submissions to the FDA for Class II and III medical devices specific to the field of cardiolog• Coordinated the efforts of development, marketing, and clinical groups to ensure regulatory compliance in all stages of product development, testing, and clinical research

• First-line, 24-hour medical management of adult and pediatric coagulopathy patients in the ER, In-Patient, and Out-Patient settings• Coordinated the YHC multidisciplinary healthcare team (physicians, surgeons, nurses, social workers, physical therapists, and dentists)• Assisted attending physician with writing and submission of all NIH, HHS, and corporate grants for numerous research projects• Co-investigator responsibilities included writing IRB proposals and follow-up communications and data management for numerous research protocols, government grant programs/services, and CDC surveillance studies (hepatitis, HIV, CJD)• Designed and maintained comprehensive databases for the entire division of Pediatric Hematology• Developed and implemented “Video Housecalls”, a novel telemedicine project linking patients/families, as well as clinic and Emergency Room staff, with 24-hour video access to hemophilia specialists on staff at YHC (physician, surgeon, and mid-level)• Created paperless data tracking programs, using mobile and desktop devices, for in-house and CDC research protocols• Developed and provided educational and support programs to patients, families, hospital/clinic staff, and community schools/organizations

• Designed databases, Clinical Pathways, company website, teaching tools, and sales/marketing materials• Provided on-call medical, nursing, and technical support to healthcare personnel treating patients with coagulation disorders

• Provided educational sessions for sales and management forces to identify the clients needs and to appreciate the strategic fit of Bayer products to the end consumer• Lectures covered scientific principals related to blood clotting disorders, topics of concern within the community (i.e. HIV, hepatitis) and practical applications of biological products.

• Hands-on clinical instructor for Nurse Practitioner students• Lectures for Graduate Nursing programs included: Pathophysiology and Management of Coagulation Disorders, Anemia, Hemophilia, Hematology• Preceptor for Graduate Nursing students: Pediatrics/Hematology electiveStudent Preceptor and Guest Lecturer (intermittent semesters)• Supervised independent study programs for Computer Science majors• Lectures for Graduate and Undergraduate Nursing Programs included: Medical Informatics, Hemophilia

Staff Nurse in Pediatrics• Specialized in care of school-aged children with chronic illnesses