Regulatory Services

In the regulatory services group our partnership with clients spans all phases of drug development.  We routinely provide strategic advice and consulting for pre-clinical and IND submissions all the way to NDA submissions and post-marketing trials.

TKL’s scope, experience and efficiency in regulatory consulting are strengthened through its integration with our expert clinical, medical writing and statistical teams.

• Providing regulatory project management, strategic and tactical advice, and direction for drug development.
• Building strategic relationships to achieve client and project objectives.
• We bring knowledge and experience to meet manufacturing, nonclinical and clinical regulatory requirements.
• Preparing regulatory submissions to achieve client and project objectives.
• We write, review and compile electronic and paper submissions for all aspects of the IND process through to the NDA and annual reports.
• We bring knowledge and experience in ethical and nonprescription pharmaceuticals, generic drugs and medical devices.
• Conducting critical reviews of key technical documents aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review.
• Coordinating and facilitating interactions with the FDA including serving as regulatory agent for US and ex-US clients.

Download our Regulatory Services brochure.