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
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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
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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)
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Get in touch

Call Now: +44 (0)7470 814455