Industries

Consumer Healthcare Testing

Analytical and microbiology support for over-the-counter (OTC) medicines, topical creams, gels, ointments and consumer-facing healthcare products. Identity, potency, microbial limits, preservative efficacy, container compatibility and stability — all under one quality system.

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What It Covers

Scope of Work

Identity and assay for OTC tablets, capsules, liquids, creams and gels

Microbial limits and preservative-efficacy testing (PET)

Antioxidant, preservative and active-ingredient stability

Container closure compatibility and primary-packaging studies

Topical product rheology and physical-form characterisation

Skin-sensitiser and irritant-trace testing on referral

Label-claim verification for cosmetic-borderline claims

In-use, accelerated and long-term stability studies

How We Do It

Methods & Instrumentation

HPLC / UPLC

Active-ingredient assay, related substances and preservative quantification.

UV-Vis / FTIR

Identity confirmation and qualitative comparison against reference.

LAL & USP <61>/<62>

Endotoxin and microbial enumeration for non-sterile and topical products.

Preservative Challenge

USP <51>, Ph. Eur. 5.1.3 efficacy of antimicrobial preservation.

Karl Fischer

Water content determination for actives, excipients and finished products.

pH / Viscosity

Physical-form QC for creams, gels, suspensions and emulsions.

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 (OTC and pharmacy-only medicines)

EU GMP — EudraLex Vol. 4 (where applicable)

USP <51>, <61>, <62>, <85>

Ph. Eur. 2.6.12 / 2.6.13 / 5.1.3

EU Cosmetic Regulation 1223/2009 (for borderline products)

What You Receive

Typical Deliverables

Batch CoA aligned to product specification

Microbial CoA with method-suitability evidence

PET report with log-reduction kinetics

Stability summary with shelf-life recommendation

Container-compatibility study reports

Investigation reports for OOS / OOT events

Who It's For

Sectors We Support

OTC medicine brand owners

Topical and dermatological product manufacturers

Pharmacy-only medicine manufacturers

CDMOs producing consumer healthcare lines

Brands transitioning cosmetic-borderline products to medicinal claims

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