Regulatory Readiness + Product Launch
Pharmaceutical and medtech manufacturers must be prepared for regulatory inspections and product approvals at every stage of their lifecycle. Many sites struggle because documentation is incomplete, processes are not proven or inspection expectations are not fully understood. Our Regulatory Readiness and Product Launch service prepares your facility, systems and people for successful regulatory interactions.
We help you build confidence, reduce risk and achieve smooth approvals by aligning your operations with EU GMP, FDA CFR, ISO standards and Annex 1 requirements.
Structured Inspection Preparation
Effective inspection readiness depends on clear documentation, trained personnel and proven processes.
We help clients prepare for authority, customer and internal audits with a structured, practical approach.
Support includes:
• Mock audits and inspection simulations
• Detailed readiness reviews for departments and systems
• Assessment of validation, QMS and contamination control records
• Review of batch documentation, change controls and CAPA files
• Gap identification and prioritised action plans
• Coaching for inspection behaviour and question handling
This gives your team a clear view of what regulators expect and how to demonstrate compliance.
Documentation That Withstands Regulatory Review
Strong documentation is essential for inspection success and product approval.
We help clients ensure their records are complete, consistent and defensible.
Support includes:
• Validation summary reports and traceability checks
• Review of DQ, IQ, OQ and PQ records
• CMC technical support for filings
• Updates to SOPs, logs, forms and controlled templates
• QMS alignment with EU GMP and FDA expectations
• Verification that contamination control measures are documented clearly
This reduces the risk of observations linked to documentation gaps or unclear decision-making.
Product Launch and PAI Readiness
Launching a new product requires proven processes, trained personnel and a complete validation package.
We support clients by reviewing all elements that contribute to a successful PAI and market launch.
Support includes:
• PAI readiness assessments
• Review of batch records and process validation packages
• Cleaning validation and contamination control evidence
• Stability, comparability and tech transfer documentation checks
• QP release readiness and supporting documentation
This ensures your product and facility are ready for regulatory scrutiny.
Value for Your Organisation
• Stronger performance during authority and customer inspections
• Fewer audit findings and reduced regulatory risk
• Clear and complete documentation that is easy to defend
• Better team preparedness through structured coaching
• A more predictable path to product approval or site certification
• Increased confidence in validation, QMS and contamination control measures
Clients gain a readiness programme that is practical, structured and aligned with current regulatory expectations, helping them move through inspections and product launches with clarity and confidence.
