Who we are.
GLOBAL REGULATORY AFFAIRS, LABELING & COMPLIANCE SERVICES LLC IS A FAST, DYNAMIC, INNOVATIVE GLOBAL PROVIDER OF PROFESSIONAL SERVICES.
Based in New Jersey, USA we develop and tailor global end-to-end solutions for our clients in the areas of Regulatory Affairs, Labeling, Pharmacovigilance and Regulatory Audits & Compliance, & and Corporate Compliance. Our expertise is based on over 25+ years of hands-on and successful Regulatory Affairs, Labeling and Compliance experience in the United States, Latin America and Europe, enabling us to support our clients around the world. Whether you need assistance in regulatory affairs intelligence, labeling, submissions, or require audit & compliance services or management of post marketing activities, we bring a strong understanding of the complexity and challenges of the industry and regulatory environment to be able to deliver a variety of innovative strategies and solutions.
Professional providers of English-Spanish translations of complete submission dossier including legal documents, labeling and artwork.
We offer fully integrated complex vertical and horizontal labeling services, providing complete global labeling management of portfolios for pharma companies globally.
Meet our team.
Andras J Megyeri
M.D., M.B.A, M.S.J.
A successful regulatory and pharmaceutical business executive with 25+ years of experience in Regulatory Affairs, Labeling, Regulatory and Corporate Compliance in Europe, Latin America, USA and in Global Regulatory functions. Successfully established country and regional regulatory affairs organizations (Latin America, Hungary, etc.), developed global and regional regulatory strategies, managed new Marketing Authorization (MA) application submissions, MA renewals, production site transfers and MA compliance audits. Successfully achieved more than 20 Rx-OTC switches in Europe and in Latin America. Designed and established the Novartis (NVS) Consumer Health Global Labeling department in three global locations and initiated the activities of the multi-functional Global Labeling Committee. Participated in several MHRA and EMA Pharmacovigilance inspections and successfully completed the required corrective and preventive action plans (CAPA). Redesigned the NVS Pharma global labeling process, including the regulatory section of the safety label changes process. Successfully established compliance activities and compliance departments and developed effective compliance plans including policies, SOPs, additional guidance documents and process maps, training, learning management systems and reporting.
Affiliated Professor - Medical Scholars Program of the College of Arts & Sciences, University of Delaware.
Member of the Advisory Board - Responsible to develop close collaboration and affiliation with regional/national and international Healthcare Institutions in order to improve the student's academic and pre-professional preparation for careers in medicine and related health care professions.
A Medical Doctor with an MBA from the London Business School and a Masters degree (MSJ) in Health Care and Health Technology Law with a Health Care Compliance Certification
Elly Gonzalez
Pharmacist, M.S.J.
A successful regulatory executive with 20+ years of experience in Regulatory Affairs, Regulatory Compliance and Product Labeling in Latin America, USA and Europe. Successfully managed the compilation of customized dossiers for Latin America, including legal documents, samples, labeling and artwork, and the oversight of the Spanish translators. Lead the development of regulatory strategy for Over-the-Counter (OTC), Medical Devices and Food/Dietary Supplements in USA and Latin America. She has overseen, tracked and monitored, the end-to-end global implementation of label changes from the origin of the change into commercial packaging. In the Regulatory Compliance field she has established a functional compliance action plan for the regulatory affairs department including processes, SOPs, templates, training, training matrix and systems, reporting systems, and peer review checks for labeling documents. She has extensive experience in developing and conducting training for multi-national and cross-functional teams. A pharmacist with labeling, compliance and industrial pharmacy experience, with a Masters degree (MSJ) in Health Care and Health Technology Law, and Health Care Compliance Certification.
Shirley Chen
Pharm. D., M.S., R.Ph.
A resourceful, strategic Medical Affairs and Drug Safety Executive with a doctoral degree and a successful track record of escorting CNS, ID and CV products through the commercialization process.
Experience in driving strategic and innovative use of medical and scientific data for internal and external customers and oversight in quality systems aspects of clinical operations, global drug safety and pharmacovigilance, regulatory affairs, medical
information and medical affairs compliance and other activities, including documentation review, internal process audits, investigational site, external vendor and commercial partner audits and follow- up and CAPA management.
Self-motivated leader with experience in drug development processes with knowledge of EMA and FDA regulations including GLP, GMP, GCP, GVP, ICH, OPDP, and OIG compliance.
A demonstrated track record of leading, collaborating, coaching and influencing highly matrixed, cross-functional teams comprised of high-level managers and executives.