Professional profile
About Emily
Emily Carter advises life sciences companies on cross-border clinical development, CRO and CDMO contracting, FDA regulatory strategy and China-facing compliance from Boston.
Ms. Carter is admitted in Massachusetts and New York. She holds a JD from a US law school and has fifteen years of professional experience, working in English with bar credentials on file.
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Global clinical trials now run through China sites. US counsel drafts the regulatory response; PRC counsel keeps sponsors from creating local employment, evidence and NMPA problems while remediating. She coordinates the two tracks from the sponsor side.
Enrollment lag fights are won or lost in the milestone definitions signed two years earlier. She drafts liquidated damages that survive the blame game.
What is site activation complete? EC approval, contract, drug on site or first eligible screen? Which inclusion criteria changes reset the clock and who may change them? Competitive trial density is often ignored until it is the CRO's defence.
When a manufacturing batch fails, three clocks start: disposition of material, root-cause CAPA and the commercial launch calendar. She structures allocation of liability for destroyed product, delay and lost launch windows before the failure.
When an FDA Warning Letter names a China manufacturing or clinical site, she coordinates US CAPA with PRC legal tracks: no re-imaging before forensic hold, no scapegoat firing without labour process, no invented root causes.
Data integrity is the red line. She advises on document holds, privilege-aware investigations, safety reporting clocks and insurer notice duties. Public statements are aligned so customers, distributors and regulators hear one narrative.
EU MDR and IVDR parallels are mapped where China exporters face dual-regulator enforcement. Cross-border health data and human genetic resources constraints are coordinated with local counsel.
Provide program structure, trial sites, manufacturing arrangements and any regulatory or contractual notice already received. Scope is confirmed in writing through this profile's inquiry channel.
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