stasonpharma.com

 

We can help navigate the regulatory hurdles associated with drug development and to facilitate approval of submissions by international regulatory authorities.

As part of the Stason Contract Pharmaceutical Services Group, we provide regulatory consulting services to the international pharmaceutical industry. We can help you navigate the regulatory hurdles associated with drug development and to facilitate approval of submissions by international regulatory authorities.

 

Our Regulatory Team has extensive experience with the United States FDA, EMEA and Health Canada. We work with you to achieve the objectives
set forth by the International Conference on Harmonization (ICH) to increase global harmonization of technical requirements and to ensure
that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner.

The primary focus of our regulatory team is on supporting the regulatory interests of Stason clients including strategic planning
including development, preparation, and assembly of complete submissions of INDs, NDAs and ANDAs; FDA meeting planning and
participation (CDER/CBER); Pre-IND tasks including design, preparation and review of protocols; and preparation of CMC sections of regulatory
documents. We will also assist clients in resolving complex technical and regulatory issues with FDA and other health authorities. We are
experienced in post approval change consultation (SUPAC) and can help you chose the right post approval strategy.

We help clients make sound business decisions with the understanding of the potential regulatory risks and benefits. With an average of 15+
years experience, our team has a strategic regulatory focus with attention to challenges that are inherent in the highly regulated
pharmaceutical business. We utilize critical thinking to identify and resolve problems in a proactive and innovative manner.

We can help reduce your time to market and assure success by:

a. Identifying and avoiding unnecessary studies
b. Ensuring that necessary studies are designed to provide useful information
c. Gaining FDA support for a proposed strategy
d. Minimizing potential for clinical hold
e. Providing opportunity for creative exchange of ideas
f. Proposing regulatory alternatives
g. Minimizing costs
h. Clearly defining endpoints and goals of the development program
i. Initiating early interactions/negotiations with FDA and other Health Authorities