Our consulting services span the entire life-cycle of the development process, starting with proof of concept through to support with post-approval variations.
We support our clients with strategic regulatory advice as well as guiding them on the Module 3 (CMC) data requirements so that any regulatory submission is done ”right first time” meaning fewer questions from assessors, reducing the length of the “clock-stop” and faster access to the market.
Regulatory strategy
- Non-clinical and CMC regulatory gap analysis
- Advise on regulatory pathway and acceleration strategy (PRIME, Priority review, Breakthrough therapy, accelerated approval, fast track)
- Support with developing, authoring and reviewing clinical trial and marketing authorization applications (GB, US, EU, Canada,)
- Interchangeability designation (for biosimilars)
- Orphan designations
- Compassionate use
- Conditional approvals
- Expanded access schemes
Chemistry, manufacturing & controls (CMC)
- Advise on data requirements to populate each Section of Module 3
- Review of all data and documentation
- Support with authoring Module 3 and Quality overall summary (QOS)
National Competent Authority Meetings
- Review of and support with developing briefing documents
- Support with rehearsals
- Support or lead NCA meetings
- Face to face attendance with NCA
CMC development services
- Cell line characterization
- Manufacturing process development, scale up and validation
- Stability protocols and data assessment
- Formulation development
- Specification setting
Analytical development
- Selection of physicochemical and functional assays to support characterization of substance/product
- Advise on in-process, release and stability test methods
- Assay validation
Manufacturing and supply
GMP compliance
QC testing
Batch release
Shipping and importation
Life cycle management
- Quality variations
- Product line extension
- Introduction of next generation products
Combination products
- Defining the primary mode of action (US-FDA)
- Type of device e.g. integral or non-integral (EU)
- Understanding the Medical Devices Regulation (MDR)
- Advice on responsible review centre (US-FDA)
