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NOW CONDUCTING REMOTE AUDITS

REGULATORY AFFAIRS AND COMPLIANCE SERVICES

DONE RIGHT.

Global Regulatory Affairs

Labeling and Product Information

Pre- and Post- Marketing Authorization Management

 

Comprehensive Outsourcing Solutions

Regulatory Strategy and Intelligence

Regulatory Audit & 
Corporate Compliance

Pharmacovigilance & REMS Compliance Audits

Marketing Authorization & Labeling Compliance

 

Audit and CAPA Management, including remote

Marketing and Promotion


FCPA and other relevant laws

Regulatory Education

Custom training in regulatory & compliance matters

Proven to increase participants' contribution to business

Teaching experience in Industry and Academia

ABOUT US

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. 

CONTACT US

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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contact

ANDRAS J 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

© 2020 GRALC LLC

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