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Services

Specialist analytical CMC & QC support, end to end.

Embedded leadership or targeted expert input — across biologics, cell & gene therapy and novel modalities, from early development to commercial filing.

01

Analytical control strategy

Phase-appropriate control strategies, specification setting and comparability assessments that anticipate regulatory expectations and stand up at review.

  • Specifications
  • Comparability
  • Characterisation
02

Method development & validation

Development, qualification, validation and transfer of analytical methods — robust and fit for purpose at every stage of the lifecycle.

  • Development
  • Qualification
  • Validation
  • Transfer
03

QC strategy & oversight

QC frameworks, release and stability programmes, and data integrity practices for both clinical and commercial supply.

  • Release testing
  • Stability
  • Data integrity
04

CDMO selection & management

Selecting, onboarding and overseeing analytical CDMOs — keeping outsourced work on specification, on schedule and audit-ready.

  • Selection
  • Onboarding
  • Oversight
05

IND / BLA / MAA readiness

Authoring and reviewing the analytical CMC sections of regulatory submissions, and preparing programmes for filing milestones and agency questions.

  • CMC authoring
  • Submission review
  • Filing readiness
06

Biologics, CGT & novel modalities

Deep analytical expertise across monoclonal antibodies, gene-edited cell therapies and emerging advanced therapeutics.

  • mAbs
  • Cell & gene therapy
  • Advanced therapeutics
Engagement model

Flexible support that fits where you are.

Every programme is different. Engagements scale from a focused review to embedded, hands-on leadership.

A

Expert review

A focused, independent assessment of your analytical package, control strategy or submission section — with clear, actionable recommendations.

B

Embedded leadership

Acting as your analytical CMC & QC lead — driving strategy, delivery and CDMO oversight as part of your team for the duration you need.

C

Milestone support

Targeted help to reach a specific milestone — IND, BLA or MAA readiness, a tech transfer, or a critical comparability exercise.

Not sure which fits? Let's scope it together.

Tell me where your programme is and what's coming up — we'll find the right level of support.

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