Clinical Research

Phase I, II, III, and IV Trials

Program and Project Management

Clinical Monitoring

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Akesis Blog

Update on Regulatory Contrast Between 505(j) and 505(b)(2) Regulatory Pathways

Update on Regulatory Contrast Between 505(j) and 505(b)(2) Regulatory Pathways In July of 2013, Akesis posted a white paper discussing the Regulatory¬†Contrast Between 505(j) and 505(b)(2) Regulatory Pathways on our blog. This article has become a fan favorite with our readers, so we decided to update this white paper with new information and data. ¬†In …
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Regulatory Affairs

Soaring above the competition

Regulatory Interactions and Meetings

Regulatory Interface

Compliance and Auditing Services

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Therapeutic Focus

Dermatology & Topical

Ophthalmology

Women's & Men's Health

Other Therapeutics

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"Quality is not an act,

it is a habit."

-Aristotle

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Akesis is a global contract research organization (CRO) with a proven Quality by Design system.

Akesis delivers clinical research services and regulatory affairs consulting. Our clinical expertise lies in dermatological, ophthalmic, and topical products for a variety of indications. We serve the biotechnology, device, formulation development, generic, and pharmaceutical industries. As your strategic partner, the Akesis team emphasizes quality, accountability, timeliness, and budget management to help clients meet regulatory standards, maintain compliance, and assure integrity.


Clinical Research

Our team has extensive and broad-ranging experience successfully collaborating in over 60 dermatology and topical programs.

Regulatory Affairs

Akesis employs highly qualified and seasoned individuals with intimate working knowledge of the FDA.

Therapeutic Focus

Our clinical expertise lies in dermatological and topical products for a variety of indications.

Quality

At Akesis, quality is not a slogan but rather a core discipline that runs through every facet of our organization.


Study Start Up

The foundation to a successful study, our staff identifies risks, sites, and prepares the protocol.

Regulatory Consulting

Develops the most efficient pathway for regulatory review for marketing authorization.

Dermatology & Topical

In addition to our dynamic portfolio, we have direct experience with acne, rosacea, and psoriasis among others.

Quality By Design

The mindset by which the project is started and executed.

Project Management

Central to your program or project, the PM is your advocate within Akesis.

Compliance & Auditing

The right expert for your Quality, GLP, GCP, or GMP Audit.

Ophthalmology

Our areas of proficiency include glaucoma, cataracts, and antibiotic drugs.

Quality Assurance

Ensures the finished product meets or exceeds the highest standards.

Clinical Monitoring

Our experts are therapeutically trained and know the complexities of each trial.

Regulatory Applications

Experienced in 510(k)'s, ANDA, 505(b)(2), and NDA's.

Women's & Men's Health

Adept with conditions ranging from bacterial vaginosis to vaginal atrophy.

Quality Management

Quantify and qualify risks through the study.