Kalie E. Richardson Email & Phone Number

Washington, Dc, Us

Washington, District Of Columbia

Assist pharmaceutical manufacturers and distributors with FDA, DEA, and state Board of Pharmacy regulatory strategy and compliance. Draft responses to FDA warning letters, 483s, and state regulatory inspection findings. Conduct internal investigations in connection with government findings and employee complaints. Advise clients on Drug Supply Chain Security and Controlled Substances Act Compliance

Washington D.C.

Provide FDA regulatory strategy and compliance for pharmaceutical, medical device, and food companies. Advise clients on product development concerns, such as Hatch-Waxman and pediatric exclusivities, labeling carve-outs, and orphan drug designation. Draft expanded access policies and standard operating procedures. Review advertising and promotional materials. Assist life sciences clients with antitrust and advertising FTC investigations.

Atlanta, Georgia

Comprehensive document review and analysis and preparation for depositions in an upcoming major patent litigation.

Atlanta, Georgia

Drafted a Supreme Court amicus brief for Commil USA, LLC v. Cisco Systems, Inc. on the role of good faith belief in patent invalidity in induced infringement. Coauthored case summaries for a review paper to identify patent law trends.

Silver Spring, Maryland

Conducted extensive legal and patent research on new chemical entity and Hatch-Waxman drug exclusivities as applied to specific drugs. Drafted portions of responses to industry inquiries and citizen petitions regarding FDA regulations.

Atlanta, Georgia

Drafted licensing agreement enforcement letters for the use of protected intellectual property. Review and approve event contracts and permission requests to use copyrighted material.

Atlanta, Georgia

Reviewed memoranda of understanding, drafted letters, conducted multidisciplinary research. Performed legal research and analysis specific to the implications of Ebola in America.

Bogotá, Colombia

Received a grant to conduct legal research and interviews with attorneys in Spanish to better understand the legal history and barriers to abortion access in Colombia as a part of a multidisciplinary team. Currently writing a paper on findings.

Toronto, Canada

Functioned as bilingual primary point of contact for several hundred dermatology and rheumatology offices in Ontario and Quebec for Enliven, patient support program for biologic medication, Enbrel. Negotiated with public and private insurers to advocate for drug coverage for thousands of patients in collaboration with doctors, pharmacists, and nurses.

Toronto, Canada

Edited and translated marketing, scientific, regulatory, and training materials for the Canadian division of a generic pharmaceutical manufacturer. Edited technically detailed pharmacologic information including product monographs, patient information leaflets, and pharmaceutical packaging in French and English.

Doctor Of Law (J.D.)

Activities and Societies: Legal Association for Women Students, Student Legal Services, Street Law

Honours B.A., Translation