Professional Services


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FDAMap provides regulatory consultation and quality assurance services to companies regulated by the US FDA, EMA and similar agencies in other countries. 

Our major regulatory consulting services include:
  • Product Development Strategy: Gap analysis, IND/IDE enabling strategy, product development plans, investment portfolio analysis.
  • US FDA Compliance: Pre-IND, EOP2, pre-NDA and other meetings with FDA, clinical trial planning/development/ management, IND/IDE/NDA/BLA/PMA creation, regulatory filing, submission, follow-up and revisions, 505(b)(2) regulatory pathway, electronic submissions to FDA, and 510(k) approval.
  • Quality Assurance and Quality Control: Preparation for Audits by FDA (GMP/GCP/GLP), GMP Certification, Process Validation Review (process, software and method), Responding to Audit Findings (e.g., FDA 483, Inspection Report Response), Testing Requirements, cGMP Consulting for Manufacturing Process and Facilities, and  Adverse Event Consulting.
  • US Authorized Agent Services:  Representing to US FDA for license, registration, import-export, and regulatory filings.
  • European Medicines Agency (EMA) Compliance – IMPD, MAA, Meetings, Audits, and strategy development and execution.
  • Pharmacovigilance: Post-market Surveillance, Patient Support (Toll-free, online and email support and reporting), REMS, Registry studies, Annual Reports.
  • Clinical Trials: Regulatory Consulting for Clinical Trials, Recruitment strategies, Advertisement campaigns, Social Media Campaigns, Patient Support (Toll-free, online and email screening).

For inquiries on FDA regulatory services and quality assurance solutions, please contact Prashant Kumar at 410-501-5777 or write to pkumar@fdamap.com 
Inquiry Form:
+1 410-501-5777
+1 877-566-4981