Welcome to Akesis
“Quality is not an act, it is a habit.”
AKESIS is a quality-driven global contract research organization whose focus is purely dermatology clinical research services and regulatory affairs consulting. We serve the pharmaceutical, device, generic, formulation development and biotechnology industries. As your strategic partner, the Akesis team provides a unique form of customer advocacy, emphasizing quality, accountability, timeliness and budget management that help clients meet regulatory standards, maintain compliance, and assure integrity.
AKESIS DELIVERS Comprehensive Pharmaceutical Development Services Including:
§ Project & Program Management
§ Conduct of Phase II-IV trials
§ Clinical Trial Monitoring
§ Oversight of Phase I trials
§ Feasibility & Protocol Development
§ Site Identification & Selection
§ Patient Recruitment Support
§ Regulatory Document Management
§ 510k Planning and Application Preparation
§ GLP/GCP/GMP auditing
§ ANDA and 505(b)(2) NDA submission preparation
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