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. We employ over 70 consultants, giving us expertise in all stages of pre-clinical, clinical, and CMC development.
We assemble carefully tailored groups of consultants for each project. This flexible structure allows us to act as an extension of each client’s team, resulting in clear, accurate, and actionable deliverables.
Kinexum’s headquarters in Harpers Ferry, WV are 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.
Ultimately, while the client is not “always right,” they have final say: we realize their vision in an ethical and legal manner.
Our consultants give crisp, clear, accurate, and practical advice. Clients are encouraged to request clarification and revisions to ensure that they understand, are comfortable with, and can implement our feedback.
For us, 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 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, each project uses only the best suited experts.
We value the community and support of our Kinexum colleagues. Therefore, 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.
Our tailored groups of consultants minimize cost to you while providing comprehensive, expert guidance and documentation.
We adopt a “growth mindset” by consistently evaluating and improving our work. Our consultants keep abreast of new regulatory and technological developments while still relying on their 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.
Client information is kept strictly confidential.
We do not discriminate on basis of race, color, religion, sex, national origin, age, disability, marital status, gender, or sexual preference. Diversity is a source of strength and creativity. Harassment (sexual or otherwise), bullying, and intimidating behavior are not tolerated.
We aspire to treat everyone with kindness, respect, and courtesy.