Global Regulatory Partners Group is a global consulting company that provides tailored Local Representation, Regulatory Affairs, Quality and Safety services for life science companies in North America, Latin America, Asia and Europe. Global Regulatory Affairs, Inc services include but not limited to: • Regulatory Strategy • IND, IMPD, IB and CTA preparation and submission. • NDA, ANDA, BLA, MAA preparation and submission. • Fast track and Orphan Drug Designation application preparation and submission. • Variations, amendments, annual reports preparation and submissions. • IDE, 510(K), PMA and CE Marking preparation and submission. • Project Management. • Medical Writing. • Advertising and Promotional Material Review and Approval • Regulatory Operation , e-submission and Publishing. • GMP Audits, ISO 13485 Audit,Quality System and Due Diligence Audits . • Pharmacovigilance and Safety.