Our Services
FDA Regulatory Consulting & Quality Assurance Solutions
FDAMap provides a comprehensive range of FDA services to companies regulated by the US FDA, EMA and similar agencies.
For inquiries on FDAMap services, please contact call at 410-501-5777 or write to info@fdamap.com
FDAMap
Major Regulatory Services
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)
Quality Assurance and Quality Control:
reparation 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).
Regulatory Services | FDA Auditing | Clinical Trial Services
FDAMap provides a comprehensive range of FDA services to companies regulated by the US FDA, EMA, and similar agencies.