Jeanne Taborsky

President and CEO

Jeanne Taborsky Jeanne holds an ACS BS in Chemistry from American University and additional post graduate training including training by University of Maryland School of Pharmacy, FDA, USP, PDA,  and GPHA.  As a pharmaceutical chemist, Jeanne has over 45 years of combined work experience at the Food and Drug Administration, United States Pharmacopeia and in industry. In 1997, she left FDA to start SciRegs. Her experience includes regulatory affairs, clinical supplies management, project planning, standards setting, pharmaceutical and cosmetic manufacturing, equipment and process validation, packaging development, analytical method development, research, and hazardous waste management. In addition to a substantial knowledge of regulations, including cGMPs, cGLP’s, Code of Federal Regulations Title 21 requirements and FDA and USP, Ms. Taborsky supervises drug development, project management, training, publishes research articles and standards, in the United States and internationally.  SciRegs has conducted and published research in dissolution testing, drug packaging and stability.

 Full Resume: Jeanne Taborsky

 

Brian Reamer

Senior Vice President and CFO

Quality Assurance and Consumer Affairs

Brian holds a BS degree in Sociology from UMBC, and training in-house through, PDA, FDA seminars and GPHA.  He started at SciRegs in 1998.  His responsibilities include financial operations for SciRegs International including projects estimates, contracts, invoicing, corporate taxes, and international tax guidelines.  His regulatory responsibilities include creating, filing and maintaining Drug Master File (DMFs), as well as conducting training of DMF holders and staff.  Brian also performs and helps clients prepare for cGMP facility audits and inspections.  Brian has set up wireless tracking of temperature and humidity for warehouse locations where drugs are processed and stored including IQ/OQ/PQ per FDA and USP requirements. Brian manages clients consumer affairs, drafting Standard Operating Procedures, and in-house management. Under contract, Brian executes and supervises the Consumer Affairs/MedWatch program for our clients; receiving questions and complaints, executing in-house investigations and periodic reports, in addition to follow-up investigations working with both distributors and manufacturers.  SciRegs MedWatch Program is conformant with US FDA requirements and subject to inspection.    

 

Elizabeth Deiss Hinish

Associate Vice President Quality Assurance

Elizabeth Deiss

Elizabeth has a degree from Catholic University and training in-house through FDA seminars and GPHA.  She started full time employment at SciRegs in 2006.   She manages SciRegs Drug Registration and Listing Program, coordinates and files facility registration and drug product listing for domestic and international clients, manages the Structured Product Labeling (SPL) electronic labeling system, and trains and manages Quality Staff.  As part of this responsibility, she also creates and designs product labeling, including bottle and carton labels, and inserts and patient medication guides, and prepares the documents for filing along with other sections of the ANDA.   As QA AVP, she is responsible for the overall quality of the ANDA submissions assuring that filings are consistent with FDA application requirements.  In addition, she manages the SOP program and QAs the training programs

 

Lori Johnson

Quality Assurance Supervisor

Lori has a degree from University of Maryland, College Park, training in-house and FDA seminars.  She has worked for SciRegs for 8 years.  She prepares and audits sections of ANDAs and DMFs filed to FDA, reviews documents, interacts with clients and supervises activities of junior staff.  She prepares and maintains project status reports, and conducts audits on approved and unapproved ANDAs.  She also files Facility and Drug Listing Registrations, conducts quality audits of labeling, generates side-by-side comparisons and generates SPL as necessary and assists in the eCTD filing.

 

Christina Condon

Quality Staff/Administrative Assistant

Christina attended Frostburg University in Maryland and has been with SciRegs since 2009.  She assists on legal cases dealing with Patent Infringement and medical complaints.  Her responsibilities also include scheduling and filing Annual and Periodic Reports in eCTD format and auditing approved and unapproved ANDAs.  She assists in the preparation of written materials including letters, meeting minutes, notices, reports, forms and presentations. She provides administrative support, including scheduling appointments, meetings, maintaining calendars, and document control. 

Chris Kahler

Quality Staff/eCTD and Computer Specialist

Chris has a certificate in graphic design and started working for SciRegs in 2007.  He has had additional training in the use of the eCTD program and the FDA Gateway submission process.  His responsibilities are divided between financial support to the CFO and regulatory matters.  He audits the formatting and visual quality of the documents, performs eCTD formatting for submissions, and submits them through the gateway.  He assists in the submission of DMF Letters of Authorization and the review of DMF documents prior to submission.  Chris assists our Computer Systems Administrator.  On the financial side,  he assists with client contracts, invoicing and internal facility records. 

 

Kate Deiss, RN

Medical Consultant and Quality Control Staff

Kate has a BA from the University of Dallas in Texas and Howard Community College in Nursing.  She has worked part time and full time for SciRegs since 2002 as Quality Control Manager.  She has worked on the preparation and auditing of ANDAs and DMFs.  She now assists part time as quality staff in Regulatory Affairs and medical consultant for the MedWatch program.   Kate was also co-author on two publications on pharmaceutical packaging.

  

Bharat D. Parekh, M.D.

Medical Advisor

Barry has degrees from Grant Medical College, Bombay, India, Internship at GBMC, in Baltimore, MD, and Fellowship in Pulmonary Medicine at the University of Maryland.  He was Board Certified in Internal Medicine in 1978 and Pulmonary Medicine in 1988.  He has held positions as Medical Director of Respiratory Medicine, Chief of the Department of Medicine, Head of Pulmonary Medicine and President of Medical Staff and at and Fallston General Hospital.  Additionally he has served as Medical Director of Respiratory Medicine, Head of Pulmonary Medicine, and UCH Cancer Committee Member at Upper Chesapeake Medical Center. He is currently a Pulmonary Medicine Clinician at VA Southern Nevada Healthcare System in Nevada and is on-call for the Pulmonary Acute Care Unit at the Mike O’Callaghan Federal Medical Center at Nellis Air Force Base in Nevada.  He has been assisting SciRegs as a medical consultant for both legal matters and the MedWatch Program for over 10 years.