Regulatory
Gsap strives to provide clients with a regulatory strategy and support which will accelerate the development and decrease time to marketing approval without compromising the safety of the patient. We provide extensive regulatory support from early development steps until regulatory approval for marketing.
Development of regulatory strategy
Gsap will work with you to develop an appropriate and effective strategy to bring your product to first in human clinical study or market.
Our team will combine knowledge of your product with years of experience with similar approvals, together with creativity. The final regulatory strategy for your product will balance risk, speed to approval and cost, to provide you with a description of the most appropriate regulatory pathway and explain why this path is the right choice.
Providing R&D support during the entire development plan
Gsap provides a development plan and leads in its execution.
Our experienced team helps companies leverage their minimal resources to execute the most efficient development plan by coordinating activities within the company and outsourcing for particular services, in compliance with regulatory requirements.
Writing and reviewing pre-clinical protocols and reports
Our non-clinical consultants can help maximize the potential for success of your product by designing a proof of concept (POC), pharmacokinetics, and toxicology studies that are appropriate to support the specific regulatory pathway, intended indication, route of administration, and duration of treatment.
Planning, writing or reviewing regulatory submissions
The requirements for regulatory submissions are complicated and open to interpretation. Gsap’s consultants will work with you to lead you through the different guidelines, with attention to similar submissions related to the proposed indication and mechanism of action, and will make sure your submission meets the relevant regulatory requirements and contains all of the required components.
Consultations with regulatory authorities (FDA, EMA, MOH)
Interactions with regulatory bodies must be carefully planned and executed, and leave the regulator with the best impression of your product and company. This requires experts with prior regulatory experience who understand the expectations and documentation required and can enable proactive discussion with the authorities regarding the steps to be taken post-meeting.
