* To assist the emerging biopharmaceutical/device company with early stage regulatory strategic planning and implementation, culminating in the filing of a successful IND/IDE with the FDA. Whether you are outsourcing a specific clinical trial management function, comprehensive regulatory affairs assistance, data management & biostatistics, need a Phase I center, or are seeking early stage product development guidance in approaching the FDA, Arkios can serve you.
Arkios BioDevelopment Int'l is a full service global biopharmaceutical consulting group, providing contract research services (CRO) to emerging technology companies developing new drugs, biologics, medical devices, and diagnostics.
Our scope is two-fold:
* To design and manage the clinical development of emerging technologies in the biopharmaceutical and device area, through successful product out-licensing or registration.
Founded in 1993 by Dr. Gary Pekoe, Arkios provides product development services for emerging technology companies in the biopharmaceutical industry.
Clients in the emerging technology arena require focused, hands-on, reliable service the first time. We provide that to each and every client. The background of our people includes strong start-up biotechnology company experience, which means we understand the culture and environment of an emerging company. We understand terms like “burn rate,” and know the importance of hitting corporate as well as developmental milestones.
Arkios is divided into two functional areas: Early Stage Product Development Services and Phase II-IV Clinical Trial Management.
Our Early Stage group conceives Strategic Regulatory Plans, develops and manages preclinical / pre-IND programs, writes and files INDs, and manages Phase I trials for our clients.
421 S. Lynnhaven Road, Suite 101, Virginia Beach, VA 23452
757-631-2114 * 757 631-2115 fax * info@arkios.com
