Our Team

Our team of skilled professionals consists of experienced regulatory experts and proficient medical writers who are well-versed in international guidelines, regulations, and best practices. We have a deep understanding of various therapeutic areas and stay up-to-date with the latest advancements in the field.

CMC documentation

• Our CMC documentation team brings over a decade of dynamic experience in the pharmaceutical industry as senior regulatory affairs professional in multiple multinational organizations with a proven track record of steering regulatory projects, orchestrating submissions, and ensuring compliance with global regulations.
• We have expertise spans various regulatory filings, including USDMF, CEP, KDMF, and Chinese DMF, WHO registration, drug product dossier (ANDA, MAA IND, NDA)

Medical Writing

• Our medical writing team comprises Ph.D. and Master’s level professionals, bringing unparalleled expertise in medical writing to the table. With a wealth of experience in crafting comprehensive documents for pharmaceutical regulatory submissions, clinical trials, and scientific publications, they have solidified their reputation as proficient communicators in the realm of healthcare. Their proficiency extends beyond mere articulation; they possess an innate ability to distill complex scientific concepts into clear and concise language, ensuring accessibility to a wide range of audiences. Their dedication to precision and adherence to regulatory guidelines have contributed significantly to the success of numerous projects, earning them respect and admiration from colleagues and collaborators alike. With an unwavering commitment to advancing medical knowledge and improving patient outcomes, this team continues to be an invaluable asset, driving excellence and innovation in medical writing