Our Services

End-to-End Biopharma R&D Solutions

NADDBio delivers comprehensive consulting services across the drug development lifecycle. From early-stage strategy through regulatory approval, we provide the expertise you need to accelerate your path to market.

Core Services

Strategic guidance and operational support to accelerate your drug development programs

01

Research & Development Consulting

We evaluate project strengths and address needs for well-controlled, compliant clinical research trials, guiding teams through the entire clinical trial lifecycle.

  • Independent monitoring & auditing
  • Data management strategy
  • FDA & international regulatory guidance
  • Strategic program optimization
02

Clinical Development

Accelerate product development through comprehensive strategy, operating model design, and process optimization across all development phases.

  • Clinical development strategy & plans
  • Target product profiles
  • Protocol & IB development
  • Medical monitoring & governance

Safety & Regulatory

Ensuring compliance and building robust safety frameworks throughout the product lifecycle

03

Pharmacovigilance

Build and optimize drug safety departments with comprehensive guidance on pharmacovigilance processes for regulatory compliance.

  • Safety risk management & RMPs
  • Case safety reports & signal detection
  • DSUR, PBRER & aggregate reports
  • Safety training & governance
04

Regulatory Affairs

Strategic regulatory planning, dossier preparation, and de-risked interactions with global health authorities.

  • FDA, EMA, MHRA engagement
  • Health Canada, TGA, ANVISA
  • CTAs, INDs, NDAs, MAAs
  • Regulatory strategy & submissions

Medical & Strategic Services

Comprehensive support for medical communications and business development

Medical Affairs

Medical communications, education, research, science liaisons, and patient support programs

Strategic Business Development

Opportunity mapping, asset assessment, valuations, and deal-making support for life science IP

Due Diligence

Clinical and safety due diligence supporting licensing deals, M&A, and asset transactions

Ready to Accelerate Your Program?

Partner with NADDBio for expert guidance across clinical development, regulatory strategy, and pharmacovigilance.