What can we do for You?

At Unicentrix Consulting, we offer a wide range of professional services designed to help you succeed. Below is a list of our core offerings. If you don’t see exactly what you’re looking for, don’t hesitate to reach out — we’re always happy to discuss your needs. If it’s not something we directly provide, we’ll gladly connect you with trusted partners who can.

Regulatory Strategy and Project Management

  • Starting from Regulatory strategy, Planning, Intelligence, Project Management and Overall Delivery
  • Represent company for pre-submission meeting with European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and EU National Competent Authorities (NCAs)
  • HA Scientific advice
  • In-licensing/ Out-licensing
  • Due diligence, Dossier audits, Dossier harmonization, Divestments/ Cancellations
  • Site/ Source transfer.

New Registration

  • EU Marketing Authorisation Applications (MAA)
    • Centralised Procedures (CP)
    • Mutual Recognition – Decentralised (MR-DC)
    • Nationals Procedures.
  • US NDA/ BLA, Canada NDS/ BLS
  • Global Markets covering seven geographical areas Non-EU Europe, CIS, Middle East, Africa, Latin America, South Asia, Asia Pacific and China
  • Orphan Designation
  • UK and Ireland Regulatory affiliate activities and product launch
  • Type II US DMF, CEP EDMF
  • UK Reclassification Applications POM to P and P to GSL.

Post-Approval

  • Variations: CMC, Clinical, Safety, Product Information update.
  • US FDA Annual Reports
  • Renewals
  • Post-approval commitments.

CMC

  • Authoring and review of Module 3
    • 3.P Drug Product
    • 3.S Drug Substance
    • 2.3 Quality Overall Summary (QoS)

Product Information

  • SmPC, PL, Labelling
  • Linguistic review
  • Mock-ups
  • PI compliance
  • Company Core Data Sheet (CCDS)

Regulatory Compliance and Conformance

  • CMC
  • Product Information/ Labelling

Only Pharma Professionals Recruitment Solutions

  • At Only Pharma Recruitment Solutions, we specialise exclusively in recruitment for the pharmaceutical industry, providing tailored solutions for companies seeking top-tier professionals:

  • Regulatory Affairs

  • Clinical

  • Quality

  • Technical and Medical Writing

  • Drug Safety and Pharmacoviligance

  • We offer flexible hiring options, including:

    • Permanent

    • Contract

    • Interim placements

  • What sets us apart is our deep industry knowledge — our recruitment experts come directly from pharmaceutical backgrounds, ensuring a precise understanding of each role’s requirements. We go beyond traditional recruitment by focusing on delivering the right talent efficiently and effectively.

  • We partner closely with our clients to understand their specific hiring needs, offering targeted and strategic recruitment solutions that deliver results.