Post Market Product Maintenance

SourcePHLEX is the one-stop solution helping global pharma companies to manage their health authority obligations, in order to focus your own resource on the most strategic assets. Our trusted, flexible and quickly available local teams leverage their experience to reduce complexity by using innovative approaches to efficiently maintain your products. Our success is proven by long-term cooperation with our clients.
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:

  • Technical / medical writing & dossier updates
  • Classification of changes
  • Dossier preparation, submissions & approvals
  • 2nd wave submissions / global roll-outs
  • Authority communication
  • Labeling / PI / CCDS management globally
  • Publishing all formats
  • VigiLit: literature surveillance
  • ICSR, signaling and risk management
  • Medical information services
  • Inspection support including mock regulatory audits to ensure MA Holder
    compliance
  • Design, implementation and remediation of your Quality Management System (QMS), in accordance with ICH Q9
  • Customer On-site Support: a convenient, tailor-made and cost effective solution for companies looking for short-, medium- and long-term resource.

Services include:

  • All RA, PV and compliance activities on a global / local level for a given portfolio included
  • Direct interfaces to manufacturing, marketing & other, limited oversight by client
  • Program governance structures with clear responsibilities
  • Performance measured via KPIs
  • PV systems outsourcing
  • Process innovation and regulatory / PV intelligence

Services include:

  • Due diligence activities (REG, PV, Compliance)
  • Strategic advice on M&A project set-up
  • Handling of operational activities during M&A
  • Database mergers
  • Site rationalization activities
  • SDEA contract management
  • Quality system, audit and inspection support

Services include:

  • Gap analysis of existing dossiers
  • Strategy consulting on manufacturing sites portfolio and second supplier options
  • Planning of site transfer variation timing (avoid out of stock situations) according to legislation in respective countries
  • Realization of CMC change control requirements
  • Operational QA work

What our clients say

There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.

Large Pharma, Global
VP Regulatory Strategy

During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

Large Pharma, Germany
VP Regulatory Affairs