Need support in the regulatory process? Let Akesis be your guide.
Our team is composed of highly qualified and seasoned individuals with intimate working knowledge of the FDA. These professionals advise on the most efficient way to design and conduct your development program to maximize success during all phases, from pre-clinical to post-approval, expediting products through clinical trials and into the market. We help clients develop strategies, examine alternatives, and identify tactics to deal with ever-changing regulatory pathway.
At Akesis, we understand the critical importance of complete and accurate regulatory submissions and collaborate on submission planning and preparation. We perform critical writing and pre-submission reviews of key technical documents to ensure consistency, scientific accuracy, completeness, and regulatory compliance. Our experience is strengthened by the contributions of our strategic partners, who are experts in the fields of data management and biostatistics, drug modeling and simulation analyses, medical writing, and packaging and label consultancy, among others.