Pharma & biotech support from development to market
Hands-on from regulatory submissions and scientific documentation to quality systems, risk assessments and lifecycle management.across EU, FDA and international markets.
Regulatory Affairs & Submissions
Clinical, Scientific Documentation and Medical Writing
Development & CMC
Quality, Compliance
Risk Assessments
Pharmacovigilance
End-to-end support across the product lifecycle
Discovery
Development
Clinical
Registration
Launch
Lifecycle
We support individual activities, specific deliverables and full development programmes.
Examples of support activities
Regulatory Affairs & Submissions
→ Module 1 preparation
→ eCTD publishing
→ eAF preparation
→ Variations (IA, IB, II)
→ Renewals
→ Lifecycle maintenance
→ Agency interactions
Clinical, Scientific Documentation and Medical Writing
→ Clinical overviews and summaries
→ Medical writing
→ Bridging reports
→ Scientific justifications
→ Literature review
→ CRO coordination
Development & CMC
→ CMC documentation
→ Technical development
→ Analytical support
→ Manufacturing documentation
→ Submission data packages
Quality & Compliance
→ GxP systems and implementation
→ Audit readiness
→ Supplier qualification
→ Inspection support
→ Risk assessments
→ Supplier qualification
→ Deviation investigations
→ CAPA support
Risk Assessments
→ Nitrosamine assessments
→ Impurity assessments
→ Contamination risk assessments
→ Environmental Risk Assessments (ERA)
→ Product-specific risk evaluations
Regulatory Affairs & Submissions
→ Risk Management Plans
→ Safety documentation
→ Signal management
→ PV system support
Confidential discussion. No commitment. Practical guidance from day one
Flexible support models
Monpharma acts as an independent senior-level advisor supporting high-impact decisions across regulated healthcare environments.
We complement internal teams with:
Project-based support
Specific deliverables.
Programme support
Development programmes.
Strategic oversight
Extension of internal teams.
Project-based support
When senior guidance is required.
Why Monpharma
Senior-level exposure
Hands-on delivery
Flexible engagement
Global regulatory experience
We can support individual deliverables or act as an extension of your team.
Independent perspective grounded in sector expertise and strategic judgment.
Confidential discussion. No commitment. Practical guidance from day one
