Global Regulatory Partners-LLC is a global consulting company that provides tailored Regulatory affairs , Quality and Safety services for life science companies in North America, Latin America, Asia and Europe.
Global Regulatory Affairs-LLC 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.