NOW CONDUCTING REMOTE AUDITS
Labeling and Product Information
Pre- and Post- Marketing Authorization Management
Comprehensive Outsourcing Solutions
Regulatory Strategy and Intelligence
Pharmacovigilance & REMS Compliance Audits
Marketing Authorization & Labeling Compliance
Audit and CAPA Management, including remote
Marketing and Promotion
FCPA and other relevant laws
Custom training in regulatory & compliance matters
Proven to increase participants' contribution to business
Teaching experience in Industry and Academia
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.
We look forward to hearing from you! Please complete our contact form, or contact our management team directly:
Andras Megyeri M.D., M.B.A, M.S.J. andras.megyeri@gralc.com +1 973 525 0425 Elly Gonzalez Pharmacist, M.S.J. elly.gonzalez@gralc.com +1 973 590 0426
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