R&D & Formulation

Product Development & Reformulation

Concept-to-launch formulation, scale-up support and reformulation for cost, stability or label-claim improvements. We sit alongside your formulators, take ownership of the analytical and stability work, and de-risk the path to launch.

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What It Covers

Scope of Work

Concept formulation for tablets, capsules, liquids, semi-solids and powders

Reformulation for stability, cost, supply-chain or label-claim drivers

Excipient compatibility and pre-formulation studies

Scale-up analytical support and process-validation analytics

Comparator-product characterisation and reverse engineering

Method development tied to the chosen formulation route

Pilot-batch release and stability for early formulation candidates

Technology transfer to chosen CDMO or manufacturing site

How We Do It

Methods & Instrumentation

HPLC / UPLC

Assay, related substances and content uniformity for development batches.

LC-MS / LC-MS/MS

Impurity ID and degradant elucidation in formulation candidates.

Dissolution

Discriminating dissolution method development for the candidate dosage form.

Karl Fischer

Water content for moisture-sensitive APIs and excipients.

DSC / TGA (referral)

Polymorph screening, glass-transition and decomposition profiling.

Forced Degradation

Acid, base, oxidation, heat and light to evaluate formulation robustness.

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.

ICH Q8 — Pharmaceutical Development

ICH Q9 — Quality Risk Management

ICH Q10 — Pharmaceutical Quality System

ICH Q1A, Q2(R2), Q6A — applied phase-appropriately

EU GMP — EudraLex Vol. 4 (where formulation is GMP-supplied)

What You Receive

Typical Deliverables

Pre-formulation feasibility report

Formulation development summary with rationale

Pilot-batch CoA and short-term stability data

Comparator-product characterisation report

Reformulation business case with analytical evidence

Tech-transfer package for downstream manufacture

Who It's For

Sectors We Support

Innovator pharma and biotech companies

Generic-drug developers reverse-engineering reference products

Consumer healthcare brands developing OTC product lines

Nutraceutical brands designing finished-product formats

CDMOs needing formulation and analytical depth

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