IND/IMPD enabling

IND/IMPD Enabling is the suite of services and documentation needed to secure regulatory authorization to conduct clinical trials, whether in the U.S. (IND) or the EU (IMPD/CTA). For small molecules, or advanced modalities, enabling activities integrate chemistry, manufacturing, analytical, formulation, toxicology, and regulatory disciplines into a unified path to filing.

Many programs stall before clinical launch because the regulatory authorities reject incomplete or poorly justified CMC, toxicology or control strategies. Without a cohesive, scientifically defensible IND or IMPD dossier, companies face delays, requests for additional studies, or outright rejections. We eliminate that risk: We craft the full enabling package – CMC, nonclinical, regulatory strategy, eCTD filing – so you advance confidently into human trials.

We act as your scientific and regulatory guide, designing the data strategy, generating required studies, and creating a cohesive submission that anticipates regulatory authority questions before they arise.

What This Stage Enables for Your Programme

By using our IND/IMPD Enabling service, you gain a scientifically integrated, regulatory-ready package that dramatically reduces the risk of rejection or surprise questions from regulatory authorities.

We create the enabling path in parallel with later phases to keep your program lean and efficient, avoiding duplicative work, enabling smoother handoffs into Phase I/II, and preserving timelines and budgets.

With expertise across both U.S. and European regulatory regimes, you retain flexibility in geographic rollout, enabling cross-region filing or coordinated submissions with minimal rework. That means a faster global footprint at lower cost and risk.