OUR TEAM

GQRS offers over 150 years of combined experience, specializing in medical devices, biotechnology, and pharmaceutical industries. We are dedicated to helping our clients take their medical devices and drugs to market as quickly and efficiently as possible.

Abdel B. Halim, PharmD, MSc, PhD, DABCC, FAACC

Dr. Abdel Halim is an internationally recognized key opinion leader with 30+ years of experience in medical device and drug industries: from strategic planning to regulatory approval.

Abdel has extensive expertise in GCP, GCLP, GLP, CE, ISO, CLIA, CAP, and CLSI regulations and guidelines - with in-depth experience in QC, QA, traceability, standardization & harmonization, risk assessment & management, and the overall QMS. Dr. Halim led and participated in audits and assessment of 100+ biotech, clinical labs, CRO, and IVD companies. Abdel has investigated and fully addressed many critical QA and regulatory incompliance issues and established satisfactory CAPA.

He oversaw the development and validation of several hundred assays on different platforms and their applications in standard-of-care and 150+ PI-PIII clinical trials. Dr. Halim has led 10 companion diagnostic programs from scientific rationale to regulatory submissions. He is one of only four professionals in the US who are triple board certified in Clinical Chemistry, Molecular Diagnostics and Toxicology, and licensed as a lab director in multiple states.

Abdel has served on 25+ governmental and public expert panels and advisory boards in the US, Canada, and EU, and contributed to 25+ committees to establish clinical and laboratory guidelines.

Maria Wallace, BSc, MSc, RN

Maria Wallace has more than 30 years of experience in clinical practice, quality assurance, and regulatory compliance. After several years of hands-on experience in clinical research, blood banking, and regulatory matters, Maria occupied several leadership positions in quality assurance over the past 20 years at global pharmaceutical companies.  Maria’s QA and regulatory experience covered different therapeutic areas in addition to diagnostic imaging.

In her career, Ms. Wallace implemented and managed global quality assurance programs. She assessed compliance of multiple sponsors, several CROs, and tens of clinical sites, defined gaps, and devised plans to fill the gaps including drafting SOPs and employing tools for harmonization of global processes and procedures.

Ms. Wallace trained, prepared, and supported staff liaised with global regulatory agencies, e.g. EMEA, PMDA (in addition to FDA), and hosted many successful regulatory inspections. Maria helped sponsors and clinical sites addressing regulatory inspection findings, drafted and reviewed corrective and preventive actions (CAPAs), and followed up on action implementations that led to successful inspection closures. She also supported clients on the resolution of inspections resulting in official action indicated (OAI) including warning letters from the FDA.

Raven Julta, MD, MBA

Dr. Jutla began her career as a surgery resident at the University of Washington and then went on to complete the anesthesiology program after 3 years of general surgery residency. Raven finished her pain fellowship at Oregon Health and Sciences University under the instruction of world-renowned clinicians of neuropathic pain and ultrasound-guided peripheral nerve blocks. In the span of 3 years, Dr. Jutla pursued the entrepreneurial side of interventional pain management to establish three busy clinics located in Washington and Oregon.  She obtained an MBA degree with specialization at the 6th world-ranked Anderson School of Management at UCLA. 

Her clinical work includes research, advisory boards, patient advocacy, medication management, percutaneous and surgical pain procedures (epidural steroid injections, diagnostic blocks, spinal cord stimulation, intrathecal opioid delivery system implantation), and medical acupuncture.  She has authored multiple papers and a book chapter in the neurosurgical residency foremost textbook, Youman's Neurological Surgery textbook. 

Dr. Jutla is a board-certified anesthesiologist, pain medicine specialist, and addictionologist. Raven is affiliated with multiple professional organizations and societies. She is the current secretary and treasurer of the Washington Chapter of the American Society of Interventional Pain Physicians.  

Donald J. Witt, BSc, MSc, PhD

Dr. Donald Witt has about 40 years of experience in laboratory medicine and medical device industry; from strategy to registration.  In his career, he has held multiple leadership positions in clinical laboratories and in-vitro diagnostic companies.

Donald's expertise covers medical device research and development, design, execution, and interpretation of associated clinical trials, quality management, quality assurance, and regulatory affairs including regulatory submissions. He has contributed and led the development of multiple diagnostic products, including companion diagnostics, for infectious diseases, oncology, immunology, and molecular profiling.

For clinical trials, Dr. Witt has participated in and led many study protocols, study designs and strategies, clinical site identifications and recruitments, analyses, and conclusions of clinical trial data, and reporting of clinical results for registration. Donald has ample expertise in regulatory affairs and submissions including 510(k), IDE, and PMA. He has formulated and submitted the device applications to FDA and other health authorities, managed the interactions with the FDA and other agency staff, addressed comments and questions, and handled regulatory audits. Donald is experienced in laboratory operational aspects including staff, project and alliance management, quality control/quality assurance, and CAP and CLIA inspections.

Shaza Halim, PT, DPT

Dr. Shaza Halim is an accomplished board-certified physical therapist with 5 years of professional experience.

Shaza is highly experienced in the examination, evaluation, and treatment of neurologically-based as well as orthopedically related musculoskeletal disorders in all age groups including pediatrics and geriatrics. She has been applying up-to-date therapeutic modalities, orthopedic approaches, and assistive medical devices to enhance treatment efficacy.

Dr. Halim is skillful in inpatient rehabilitation for post-surgical intervention and prevention of bed rest deconditioning to promote mobility and functionality. Shaza has been practicing physical therapy since 2016, evaluated and treated adult and pediatric patients with various neurological and orthopedic conditions to decrease pain, and improve mobility, function, well-being, and quality of life.

Shaza received her Bachelor of Arts in Biology and Psychology and Doctor of Physical Therapy (DPT) from Rutgers University, and she has been LSVT BIG-certified clinician since 2017.