SERVICES

We provide premium, high-impact regulatory consulting services tailored to your program, stage, and objectives.

Global and Regional Regulatory Affairs

We provide end-to-end support for regulatory submissions and agency engagement across all major jurisdictions.

  • Regulatory pathway strategy and execution
  • Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA), Category 1 (Cat 1) application and lifecycle submissions
  • Common Technical Document (CTD) dossier development and review (Modules 1-5)
  • Regulatory gap analysis
  • Agency meeting strategy, preparation and negotiation
  • Response to regulatory questions and deficiencies
  • Support with electronic CTD (eCTD) publishing and submission management
  • Regulatory intelligence and competitor insights

We don't just manage submissions - we lead them to successful outcomes.

Regulatory Strategy

We develop clear, commercially aligned regulatory strategies that reduce risk and accelerate development.

  • Global and regional regulatory strategy development
  • Target Product Profile (TPP) development
  • Pathway optimisation (including complex and accelerated pathways)
  • Development plan review (preclinical → clinical → licensure → commercialisation)
  • Risk identification and mitigation strategies
  • Strategic problem-solving for complex programs

The right strategy early can save years of development time.

Executive Regulatory Advice

We support executives and boards in making high-impact, informed decisions.

  • Strategic input into executive and board discussions/decisions
  • Evaluation of regulatory pathways (e.g. 505(b)(2), accelerated approval pathway)
  • Regulatory risk assessment for development programs
  • Gap analysis for licensing decisions
  • Interpretation of regulatory requirements

Regulatory decisions are business decisions - we help you get them right.

Training and Coaching

We design and deliver bespoke training programs to strengthen internal regulatory capability.

Training includes:
  • CTD modules (Modules 1-5)
  • Regulatory pathways across key jurisdictions
  • Preparation for regulatory agency meetings
Coaching includes:
  • Executive-level regulatory leadership
  • Project management for regulatory affairs
  • Capability building for regulatory professionals