Phase 1 through launch

Clinical and commercial manufacturing

Hands-on support to keep supply on schedule while the process matures and the quality system grows to match it.

Discuss your programme

Overview

Between the first clinical batch and a validated commercial process, requirements change at every phase. Systems that were enough for Phase 1 stop being enough, and the cost of catching up grows quickly.

We help you set the right level of GMP control for each stage, run batches with your CDMO or in-house team and prepare the site, the records and the people for launch.

What we do

Phase-appropriate GMP

A plan for what quality systems you need now, what you need by pivotal studies and what you need at launch.

Batch records and procedures

Clear, executable batch records and SOPs that reduce errors on the floor and reviewing time in quality.

Person-in-plant oversight

Experienced staff on site during critical batches, reviewing execution and decisions in real time.

Deviations, OOS and CAPA

Investigation support and root-cause analysis that regulators accept, and that stops repeat events.

Process validation and PPQ

Strategy, protocols and reports for process performance qualification, linked to your control strategy.

Quality agreements and launch readiness

Quality and technical agreements with CDMOs that assign responsibilities clearly, and a final review of supply, release and inspection readiness.

When teams call us

  • You are about to start a first GMP batch and want it to go right.
  • Deviation volume is climbing and releases are slipping.
  • You are preparing for PPQ and want to be sure the process is ready.
  • A launch date is set and the commercial supply chain is not.

How it runs

  1. Baseline

    We assess your process, systems and supply plan against the target phase.

  2. Prioritise

    We agree a ranked plan covering documents, systems, training and oversight.

  3. Support batches

    We work alongside your team through manufacture, release and investigation.

  4. Prepare for launch

    We run the final checks across validation, quality systems, supply and inspection readiness.

Common questions

Yes, on a defined-term basis for critical batches or longer periods, with clear reporting lines to your quality unit.

That is a common arrangement. We act as your technical and quality representative and work to your quality agreement.

The level of control that fits the stage of development and the risk to patients, increasing as the programme moves towards approval.

Related services

Technology transfer

Sponsor to CDMO, site to site

Audit and inspection preparation

Pre-approval and routine

Cell and gene therapy

Cross-cutting specialism

Tell us what you are facing

A thirty-minute scoping call, no charge. We will tell you honestly whether we are the right team.

Book a call