Nutraceutical & Food

Regulatory Submissions & Novel Foods

CTD / eCTD modules, variation packages and FSA / EFSA novel-food applications, all backed by analytical evidence from our own laboratory. We write the story the regulator needs and we own the data behind it.

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What It Covers

Scope of Work

eCTD Module 3 (Quality) authoring and CMC support

Variation packages (Type IA, IB, II) — analytical evidence and writing

FSA novel-food applications (UK)

EFSA novel-food applications (EU)

Health-claim and nutrition-claim dossiers

Specifications drafting for new ingredients and finished products

Stability programme design for submission support

Pre-submission gap analysis and regulator-readiness review

How We Do It

Methods & Instrumentation

Module 3 Authoring

3.2.S (Drug Substance), 3.2.P (Drug Product) sections and quality overall summaries.

Novel Food Dossier

Section-by-section authoring per FSA / EFSA guidance.

Specification Design

ICH Q6A-aligned specifications with justification.

Method Lifecycle

ICH Q14 and Q2(R2) consideration for analytical sections.

Stability Strategy

ICH Q1A / Q1E-aligned design and shelf-life justification.

Gap Analysis

Documented pre-submission assessment with closure plan.

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.

MHRA (UK) and EMA (EU) submission frameworks

EU Regulation 2015/2283 — Novel Foods

FSA Novel Food Application guidance

ICH Q1, Q2, Q3, Q6, Q8, Q9, Q10, Q11, Q14

eCTD Specification — current EU module 1

What You Receive

Typical Deliverables

eCTD-ready Module 3 sections

Variation application packages

FSA / EFSA novel-food dossiers with safety dataset

Health-claim substantiation packages

Pre-submission gap analysis with closure plan

Regulator-response support packages

Who It's For

Sectors We Support

Pharma companies preparing UK / EU submissions

Generic / biosimilar developers

Nutraceutical brands launching novel ingredients

Food and beverage manufacturers needing FSA / EFSA approval

CDMOs supporting client submissions

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