ADVANCEONE

Negotiating quality contract agreements

Providing training on preparing regulatory filings and on GMP/GLP compliance for small molecules, biologics, and drug-device combinations

Technical writing for others; technical writing of development reports to support process validation, manufacturing and regulatory filings

Tracking and monitoring regulatory compliance requirements for biopharmaceutical, small molecule, and medical device products; performing regulatory compliance audits; Regulatory compliance consulting regarding developing appropriate regulatory programs, assisting with response to regulatory authorities, advising on global submission requirements, and consulting regarding global regulatory submission support conducting gap analyses and risk assessments and preparing global submissions to the FDA and other drug and medical device regulatory authorities