Discovery Phase to Market Authorization

InnoPHLEX is the comprehensive end-to-end solution for specialized pharma and biotech companies to drive successful product development. We accelerate your product’s time-to-market and help mitigate risk by engaging our range of subject matter experts. Benefit from our extensive local network of health authority connections to help navigate you through the regulatory process. The services included within this bundle can include anything from development consulting, regulatory affairs, pharmacovigilance to quality and compliance. All services are tailored to your business needs.

Services include:

  • Coordination of development projects and submissions
  • Product development plan regeneration

Services include:

  • Product characterization
  • Support of formulation and analytical method development
  • Process validation
  • Quality by Design (QbD)
  • Continued process verification and accelerated development strategies
  • Definition of critical quality attributes and specifications
  • Release and stability testing strategies

Services include:

  • Health authority meetings
  • Gap analyses of regulatory and scientific documents
  • Assessment of special designation opportunities
  • Due diligence evaluations

Services include:

  • Program design
  • Protocol development and review
  • Vendor selection and oversight

Services include:

  • Clinical development plan
  • Study design
  • Protocol development and review
  • CRO selection and oversight
  • Study management
  • CSR writing

Services include:

  • CMC/Quality by Design (QbD)
  • Non-clinical and clinical studies, e.g. SAPs, meta-analyses, ISS/ISE support, PK/PD modelling, CDISC compliance, focus expertise in adaptive design and Bayesian designs

Services include:

  • Clinical study safety surveillance
  • SAE reporting
  • Individual case report processing and follow up
  • Authoring of risk management plans (USA/EU)
  • Provision of PV system, including QPPV, DSUR report preparation

Services include:

  • Pediatric development plans
  • Orphan designation applications
  • Briefing books for health authority interactions
  • Applications for special consideration, e.g. PRIME, adaptive pathways
  • Investigator brochures
  • Non-clinical overviews and summaries
  • Environmental risk assessments

Services include:

  • QMS development and maintenance
  • GxP vendor qualification
  • GxP audits
  • Inspection support and remediation
  • Pre-approval inspection readiness (PAI)

Services include:

  • Technical dossier compilation
  • Publishing and validation
  • eCTD consultancy and electronic submissions
  • Document templates and document formatting support

Services include:

  • Filing of registration documentation
  • Procedural advice and management for US, EU and growth markets
  • Liaison with regulatory agencies globally
  • Delivery of local and global regulatory intelligence

Services include:

  • Company core data sheet (CCDS)
  • US and EU regional product information sheet

A convenient. tailor-made and cost-effective solution for companies looking for short-, medium- and long-term resource.

What our clients say

Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

Leading European Specialist Pharma Company
Head of Medical Writing and Publications

We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.

Small Medium Sized Company, UK
Head of Regulatory Affairs