Brian Kirk, Ph.D. Email & Phone Number

𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞 𝐢𝐧 𝐂𝐌𝐂 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐟𝐟𝐚𝐢𝐫𝐬 Experienced in authoring Quality Modules (Modules 2.3/3) of regulatory submissions for drugs (small molecules) and biologics. Submission lifecycle experience spans from clinical development phase to commercialization and post-approval changes. Adept at preparing CMC sections of investigator brochures, pharmacy manuals, meeting briefing books and correspondences with health authorities. Implemented early- and late-phase CMC regulatory strategies and risk management principles to positively impact product lifecycle maintenance. CMC regulatory expertise is grounded in extensive direct experience in chemical development, analytical testing, and manufacturing. Both US and ex-US submission filing experience including IND/IMPD/NDA/MAA/BLA/Brexit eCTD baseline and common LCM (annual reports, IND/IMPD (information) amendments, variations, supplements, line extensions, etc.).𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐅𝐢𝐥𝐢𝐧𝐠𝐬 𝐛𝐲 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜 𝐌𝐨𝐝𝐚𝐥𝐢𝐭𝐢𝐞𝐬✔️ Small Molecules