Successful product development depends on making the right decisions early. Scientific Advice provides a valuable opportunity to obtain feedback from regulatory authorities before critical development milestones, helping companies align their regulatory, nonclinical, clinical and CMC strategies with agency expectations.

Peritus S2PD supports biopharma, biotech and medical device companies in preparing for, managing and responding to Scientific Advice interactions with global health authorities. Our experts help clients maximise the value of regulatory engagement and convert agency feedback into practical development strategies.

Why Scientific Advice Matters

Many development delays and costly programme changes occur because key regulatory expectations are identified too late. Scientific Advice can help companies:

• Confirm development strategies before major investment decisions
• Validate nonclinical, toxicology and clinical development plans
• Align CMC development with regulatory expectations
• Identify potential regulatory risks early
• Reduce the likelihood of delays during IND, CTA, NDA, BLA or MAA submissions
• Strengthen investor confidence through regulatory validation

Our Scientific Advice Services

Peritus S2PD provides comprehensive support throughout the Scientific Advice process:

Strategic Planning

• Gap analyses and regulatory readiness assessments
• Identification of key regulatory questions
• Development of agency engagement strategies

Briefing Package Preparation

• Regulatory briefing books
• Nonclinical and toxicology summaries
• Clinical development strategy documentation
• CMC development and manufacturing summaries

Meeting Support

• FDA Type B and Pre-IND meetings
• EMA Scientific Advice and Protocol Assistance
• MHRA Scientific Advice meetings
• Orphan Drug and Innovation Office interactions
• Global regulatory authority engagements

Post-Meeting Support

• Analysis of agency feedback
• Development plan updates
• Risk mitigation strategies
• Regulatory roadmap development

Supporting US Companies Expanding into Europe

Many US biotech and medtech companies have extensive FDA experience but require specialist support when engaging with European regulators.

Peritus S2PD helps US companies navigate:

• EMA Scientific Advice procedures
• Protocol Assistance for orphan medicines
• MHRA Scientific Advice pathways
• Clinical Trial Application (CTA) requirements
• Integrated FDA, EMA and MHRA regulatory strategies

Our team bridges the gap between US and European regulatory expectations, helping companies develop globally aligned programmes.

Integrated Expertise

Unlike traditional regulatory consultancies, Peritus S2PD combines expertise across Regulatory Affairs, Toxicology, Clinical Development and CMC. This integrated approach ensures Scientific Advice packages address the full development programme rather than individual disciplines in isolation.

By bringing together multidisciplinary expertise, we help clients present robust development strategies and obtain meaningful regulatory feedback that supports successful product development.