About

Navigating the complex regulatory landscape is crucial for ensuring compliance and accelerating market entry for pharmaceutical products. At T-Pharma Lab Inc., we offer comprehensive regulatory affairs services tailored to support pharmaceutical companies, biotechnology firms, and medical device manufacturers. Our expertise spans across various regulatory pathways, enabling our clients to achieve seamless approval processes and maintain compliance with evolving regulations.

Our Expertise

Our team of regulatory professionals provides strategic guidance and hands-on support throughout the product development lifecycle. We specialize in:

• Regulatory Strategy Development – Assisting with regulatory pathway selection and submission planning.

• Dossier Preparation & Submission – Compiling and submitting high-quality regulatory documentation for new drug applications (NDAs), abbreviated new drug applications (ANDAs), investigational new drug (IND) applications, and medical device submissions.

• CMC Regulatory Compliance – Ensuring Chemistry, Manufacturing, and Controls (CMC) sections meet regulatory expectations.

• Health Authority Interactions – Managing communications and meetings with regulatory agencies such as the FDA, Health Canada, and EMA.

• Regulatory Gap Analysis – Evaluating existing data to identify compliance gaps and recommending solutions.

• Post-Approval Regulatory Support – Handling variations, renewals, and post-marketing requirements.