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Services
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QP / RP services

Dedicated QP and RP support for batch certification, GDP oversight and continuity.

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// What we do

QP / RP services

QP and batch release

  • Dedicated QP team, backup and contingency
  • Batch review and batch disposition
  • Batch certification and release
  • Release system set-up and improvement
01

RP and distribution

  • Dedicated RP, backup and contingency (EU GDP)
  • Storage and distribution oversight
  • Customer qualification
  • Complaint management
02

Quality and continuity

  • Quality management oversight
  • Authority liaison and inspection support
  • Interim QP, RP, QA and Operations leadership
  • Transition, mentoring and specialist support
03
// Our expertise

QP / RP scope

Batch review and certification

Batch review and certification

  • Commercial and IMP batch review, disposition and certification
  • Batch records, deviations, investigations and EU Annex 16 evidence
  • Release system set-up, improvement and certification-to-distribution handover
  • Release evidence map, lifecycle checklist and oversight records
RP and GDP oversight

RP and GDP oversight

  • Dedicated RP, backup and contingency arrangements
  • Storage, cold-chain and ultra-cold routes; lane risk and temperature reviews
  • Customer qualification, transport partner approval and returns
  • Excursions, complaints, quality defects, recalls and mock recalls
Quality oversight and authority liaison

Quality oversight and authority liaison

  • GMP oversight across manufacturing, QC, MS&T and supply chain
  • Quality agreements, deviations, CAPA and change control
  • Authority interactions, inspection preparation and responses
  • Governance routines, action tracking and controlled documentation
Interim leadership and continuity

Interim leadership and continuity

  • Interim QP, RP, QA and Operations leadership
  • Support for vacancies, restructuring and workload peaks
  • Continuity risk assessment, backup plans and escalation routes
  • Prioritised work programme and documented handover
Coaching and specialist support

Coaching and specialist support

  • Mentoring for new QPs, QA managers and technical specialists
  • Leadership development and regulatory-interaction coaching
  • MS&T, aseptic processing, CCS, QMS and data integrity expertise
  • Cold-chain and distribution support; technical recommendations
Transition and project recovery

Transition and project recovery

  • Technology transfer, new products and site expansion
  • QMS modernisation, eQMS and MIA preparation or scope extension
  • Lean improvement, SOP harmonisation and training matrices
  • Production-line training, crisis assessment and project recovery
  • Remediation roadmaps, KPI follow-up and handover
Colleagues discussing operational and quality priorities
Working alongside your team

QP / RP expertise and continuity

For an ongoing QP or RP role, a temporary vacancy or a transition, we work alongside your quality and operational teams. The assignment connects release decisions, distribution oversight and a practical handover.

Dedicated support and backup

A defined QP or RP role, with backup arrangements and agreed escalation contacts.

Operational handover

Documented procedures, release evidence and team preparation to maintain continuity.

  • Batch review and certification
  • GDP and distribution oversight
  • Interim leadership and backup
  • Mentoring and handover

What do you need help with?

Tell us about your site, your situation and the timing you have in mind.