ICON recognises the importance of strategic analysis and decision-making in drug and device development
We have a strong track record in advising clients through the development continuum. ICON subject matter experts provide guidance across:
- Strategic and Regulatory Planning – Identifying and supporting label claims and strategies for effective product application, regulatory strategy planning and development for all sections of INDs, CTAs, MAAs and NDAs; pharmaceutical and biopharmaceuticals GMP and GLP compliance, due diligence assessment and compliance strategies.
- Preclinical / Non-Clinical Development – GAP analysis, due diligence assessments, nonclinical development (small molecules, biologics, medical devices), translational sciences and pharmacokinetics (nonclinical, modelling).
- Chemistry, Manufacturing & Controls (CMC) – integrated, global CMC services for small molecules and biologics. A flexible, collaborative consulting approach to address specific areas or comprehensive CMC strategy.
- Clinical Development – protocol design for adaptive and traditional approaches, full clinical development plans, from First in Human to end of product lifecycle, biosimilar development, scientific oversight of- and operational support for development projects, and compliance.
- Regulatory Strategy – regulatory development strategy, clinical trial and marketing authorisation submissions, post-licensing and post-market support.
- Commercialisation & Outcomes - Health economics and outcomes research, pricing & market access strategy, value proposition development and payer engagement.