About Kinexum
Kinexum / n. [Kine, Gr, motion, energy; Nexum var. nexus, L, tying together, connecting]
1. The intersection of health product discovery, development, regulation, and market integration.
2. The energy and effective motion resulting from a culture of trust, openness, collaboration, and innovation.
Since 2003, Kinexum has provided regulatory consulting services across a broad set of modalities and therapeutic areas throughout the world. Our consultants help clients in all stages of pre-clinical, clinical, and CMC development.
Our flexible structure allows us to act as an extension of a client’s team. Our subject matter experts carefully and efficiently produce clear, accurate, and actionable deliverables.
Harpers Ferry, WV, where Kinexum is headquartered, is 75 minutes from the FDA.
Our Pillars
No matter the effort that we put into a project, we assess the outcome based on its value to the client. We strive to satisfy our clients with the quality, speed, and cost of our work.
While the client is not “always right,” we recognize that they have final say and realize their vision in an ethical and legal manner.
We provide crisp, clear, accurate, and practical advice. As needed, we provide clarification and revisions to ensure that our client understands, is comfortable with, and can implement our advice.
We understand that achieving a given regulatory milestone is not an end but a means to help patients and create value for our clients. We act as an extension of a client’s management team, using our expert knowledge to help that client improve upon and realize their broader corporate strategy.
We take a collaborative approach that incorporates the diverse perspectives and experiences of our colleagues. While all of our consultants are highly knowledgeable, we identify the experts best suited for each project and client.
We value the community and support of our Kinexum colleagues. We foster an environment of professional respect and courtesy internally and with clients, vendors, regulators, and others.
We apply “speedquality” to all of our projects. This term was coined by the late Dr. Leigh Thompson, Eli Lilly CSO, who stressed that every spent in development can cost lives. We complete projects as quickly as possible while still ensuring high-quality output.
We assemble a tailored group of consultants for each product to minimize cost to you while providing comprehensive, expert guidance and documentation.
We adopt a “growth mindset” by consistently evaluating and improving our work. We keep abreast of new regulatory and technological developments while still relying on practical experience.
We pride ourselves on “pulling rabbits out of the hat” for clients. At the same time, our ultimate responsibility is the development of safe and effective products for patients.
Our consultants uphold duty of integrity (doing the right thing), duty of care (competence), and duty of loyalty (to Kinexum and the client, within bounds of law and ethics). We honor the Kinexum brand and our reputation with the FDA, other regulatory agencies, and third parties.
We keep client information strictly confidential.
We do not discriminate on basis of race, color, religion, sex, national origin, age, disability, marital status, gender, or sexual preference. We believe diversity to be a source of strength and creativity. We do not tolerate harassment (sexual or otherwise), bullying, or intimidating behavior.
We aspire to treat everyone with kindness, respect, and courtesy.