Consultant services for pharma and biotech from development to Marketing Authorisation
Pre-Approval solutions
Science and business go hand in hand. We support your product development with the end goal of market entry in mind. Regulatory compliance is key for building a strong business case in pharma and biotech.
Our cross-functional team of experts offer guidance and support for compliance across regulatory affairs, quality assurance and safety.
Speak the language of Marketing Approval
Accelerate your path to approval
Build your MAA strategy for clarity, quality, and success. Our experienced team has a proven track-record of successful preparation and management of Marketing Authorisation Applications.
Regulatory Affairs & CMC
With the right expertise in regulatory affairs and CMC, complex requirements are transformed into clear, manageable development pathways. Experienced guidance helps you anticipate challenges, as well as design compliant and efficient development strategies. Ultimately bringing innovative therapies to patients.
Quality Assurance
Experienced quality assurance specialists translate complex requirements into practical, efficient quality systems that support development rather than slow it down. Their expertise helps you establish the right processes, documentation, and oversight from the outset, reducing compliance risks and preventing costly delays.
Launch readiness expertise
Whether you are planning to market your product after approval, or to divest it, your strategy should include a market access perspective. Early alignment of commercial strategy with regulatory and clinical development, will help you optimise pricing outcomes and patient access.
Key services in early phase pharma
Our cross-functional team of experts offer strategic advice and operational excellence across regulatory affairs, quality assurance and pharmacovigilance. With a joint perspective of compliance and commercial competitiveness, we support your journey from development to approval.
Regulatory strategies
- Regulatory strategy plan
- Scientific advice
- Target Product Profile (TPP)
- Quality Target Product Profile (QTPP)
- Risk assessment
Regulatory pathways
- Regulatory timelines
- Orphan Drug Designation
- Pediatric Investigational Plan (PIP)
- PRIME designation
Regulatory support
- Project management
- Documentation management
- Publishing support
- Agency interactions
Clinical trials
- Clinical and product development
- IMPD writing
- Medical writing
- IMP labelling
- CTIS submission
CMC strategy and support
- CMC development plan
- Formulation development strategy
- Analytical method validation advice
- Impurity profile and spec limits
- Tech transfer support
- Combination product development
Early market access
- Landscape review
- Unmet need
- Market potential
Investor/Exit strategies
- Due diligence readiness
- Gap analysis
- Supply chain robustness
- Quality data room setup and maintenance
- Workstream leads
QA support
- Validation/qualification
- Document management systems
- Self-inspections
- Acting QP services
Supplier management
- Audits (GMP, GLP, GDP)
- Quality agreements
- Tech transfer support
Training
- GXP overview
- GMP (in depth)
- GLP (in depth)
- GDP (in depth)
QMS
- SOP writing
- Offer for small startups: Small efficient fit-for-purpose QMS
Your contact person
Delphine Guérin