Regulatory Strategy

Kineticos’ customized approach to clinical and non-clinical development enables innovators at all stages to meet the complex needs of worldwide regulatory agencies. With Kineticos’ expert regulatory support, our clients can make more timely and informative decisions in regards to their clinical and non-clinical development. Across Pharma and Biotech, Kineticos’ clients benefit from our hands-on approach and our teams ability to deeply understand the underlying science and technology, engage key stakeholders, enable meetings with regulatory agencies, and hold strategic conversations.

Our network, expertise, and passion for the life sciences fuel our work to help our growth-minded clients achieve success in bringing life-saving therapeutics to the people who need them.

Global Product Development

Indication Prioritization and Selection

Regulatory Landscape and Trends

Technical Scientific Due Diligence/Gap Analysis

IND/NDA/BLA Strategy

Regulatory Preparation and Submission Support

Health Authority Meeting Support (FDA/EMA/MHRA)