Phase I, II, III, and IV Trials
Program and Project Management
Clinical MonitoringRead more
Regulatory Interactions and Meetings
Compliance and Auditing ServicesRead more
Dermatology & Topical
Women's & Men's Health
Other TherapeuticsRead more
Our team has extensive and broad-ranging experience successfully collaborating in over 60 dermatology and topical programs.
Akesis employs highly qualified and seasoned individuals with intimate working knowledge of the FDA.
At Akesis, quality is not a slogan but rather a core discipline that runs through every facet of our organization.
The foundation to a successful study, our staff identifies risks, sites, and prepares the protocol.
Develops the most efficient pathway for regulatory review for marketing authorization.
In addition to our dynamic portfolio, we have direct experience with acne, rosacea, and psoriasis among others.
The mindset by which the project is started and executed.
Central to your program or project, the PM is your advocate within Akesis.
The right expert for your Quality, GLP, GCP, or GMP Audit.
Our areas of proficiency include glaucoma, cataracts, and antibiotic drugs.
Ensures the finished product meets or exceeds the highest standards.
Our experts are therapeutically trained and know the complexities of each trial.
Experienced in 510(k)'s, ANDA, 505(b)(2), and NDA's.
Adept with conditions ranging from bacterial vaginosis to vaginal atrophy.
Quantify and qualify risks through the study.