Fdainsight, llc email format

Company Details

Founded

-

Address

1622 Nordic Hill Circle, Silver Spring,md 20906,united States

Industry

Business Consulting And Services

Keywords

FDA Expert Witness Services, Hatch-Waxman Act (ANDAs) and BPCIA (Biosimilars) Cases, Patent Infringement and Invalidity Analysis, Quality Management and Strategic Planning, Quality System Development, Quality Control Program Development, Batch Release Oversight, Phase Based Regulatory CMC development, Preparation, writing and review of CMC and Labeling sections of FDA submissions (INDs, NDAs, BLAs, 510(k) and PMA documents), Product quality and CMC Gap assessment, Regulatory Inspection Response Preparation, Import and Export guidance, Clinical Management, Bioequivalence study design and site management, Preclinical Discussions with FDA and the International Regulatory Authorities, Pre IDE/IDE/IND meetings, Clinical Trial Management Protocol Development, IRB and Ethics committee review, Clinical site selection and GCP auditing, Compliance Management, PAI, cGMP and BIMO Inspection Readiness Preparation, Technical Due-diligence and Data Integrity Audits, Vendor Qualification Audits, Response to FDA-483s, Consent decrees, Import bans and oversight, CMO and Contract Labs Assessment and Quality Agreements, USP <787> and USP <800> compliance for Hazardous Drug Compounding.

HQ

Silver Spring, MD

Competitors

GRIN Quality Consulting & Training, Consulting BARO Inc., Pharmazone, Africa Clinical Trial Solutions (ACTS), Alentis Therapeutics, AuditVantage Solutions, Oscar GCP Consulting.