Regulatory Affairs

Utilize Jyton's proven expertise and comprehensive global services for the most effective regulatory assessment and strategy for all stages of product development. Our reputation for high quality submissions comes from our experience helping our clients succeed.

Comprehensive Regulatory Services

With interdisciplinary teams and extensive internal resources, Jyton's regulatory affairs staff is flexible and responsive to your needs. Our regulatory consulting services include:

• Scientific advice
• Competitive intelligence surveys
• Regulatory strategy definition
• Submission strategies
• Clinical trial applications, maintenance and trial support
• Pharmacovigilance processes
• Marketing applications
• Launch and post-approval activities

Product and Therapeutic Experience

Jyton has developed regulatory strategies derived from novel scientific research, biotechnology and advanced therapeutics for a wide array of products (new chemical, biological, medical devices). With a variety of therapeutic backgrounds, our staff covers all major areas of research and development.

Global Expertise

Jyton's strength lies in our global network and relationships with regulatory authorities. With offices worldwide, we understand global regulatory requirements and submission strategies, and act as a diplomatic and effective liaison with regulatory authorities.

Program managers

Serving as client advocates within Jyton, program managers bring a wealth of experience and strong leadership skills to design and execute efficient development programs for your products.

Chemistry, Manufacturing and Controls (CMC) / Toxicology Consulting

Jyton's global resources and expert staff help you create CMC/Tox programs that are fully integrated with the clinical and regulatory plans of your product development program.

Strategy and Meetings

With expertise honed through the preparation of successful development plans, Jyton's experienced professionals assess strategies and risk, and facilitate or participate in regulatory authority meetings.

Submissions

Experienced with regulatory agencies worldwide and with complex multinational processes, Jyton prepares all major regulatory submissions and provides extensive quality control review.