Life Science Training & Consultancy

Practical training and consultancy for pharma, nutra and food teams. We help your scientists, QC analysts, QPs and quality managers get fluent in GMP, method validation, stability, regulatory dossiers and inspection-readiness — delivered remotely, on-site, or as bespoke programmes.

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What It Covers

Scope of Work

GMP fundamentals for new starters and laboratory staff

Method validation against ICH Q2(R2) — workshops with worked examples

Stability programme design — protocols, pull-points, ICH Q1A/Q1E evaluation

Specifications and regulatory rationale per ICH Q6A

OOS / OOT investigation methodology — root-cause workshops

Inspection-readiness coaching — mock audits, deficiency-letter response

Regulatory writing — Module 3 (Quality), variations, novel-food dossiers

Bespoke client-site training — tailored to your products and quality system

How We Do It

Methods & Instrumentation

Live Workshops

Half-day, full-day or multi-day workshops, on-site or via video conference.

Worked Examples

Real (anonymised) data and case studies — analysts leave with templates, not just slides.

Bespoke Programmes

Built around your specific products, methods, quality system and audit history.

Mock Audits

Walk-through against MHRA / EU GMP expectations with prioritised gap report.

Document Reviews

Specification, protocol, validation report and Module 3 reviews with markup.

Coaching

Ongoing 1:1 coaching for QPs, QC heads or regulatory leads.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

EU GMP — EudraLex Vol. 4

ICH Q1A · Q2 · Q6A · Q9 · Q10

MHRA Inspection Expectations

EMA Q&A on Variations

USP / Ph. Eur. General Chapters

FSA / FSS Novel Foods Guidance

What You Receive

Typical Deliverables

Course materials (slides, exercises, templates)

Attendance certificates for each delegate

Gap report following mock audits with prioritised actions

Marked-up specifications, protocols, reports or dossiers

Bespoke SOPs and quality-system documents (where commissioned)

Follow-up Q&A clinic for course alumni

Who It's For

Sectors We Support

New QC analysts

Quality managers preparing for inspection

QPs new to UK / EU regulation

Regulatory teams writing first dossiers

CDMOs onboarding clients

Nutra and food teams entering regulated markets

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