Expertise
Pharmaceutical microbiology sits at the centre of everything we do. From contamination control to compliance, our consultants combine hands-on lab experience with a sharp eye for what regulators expect.
Contamination rarely announces itself until a result you can't explain. We trace it back to the source across people, materials, equipment and environment, and build a control strategy your team can keep running.
Aseptic processing leaves little room for error. We design, redesign and validate the processes that keep sterile product sterile, against Annex-1 and cGXP, alongside your contamination control strategy.
A monitoring programme is only useful if it tells you something before a result does. We build and review environmental and utility monitoring for cleanrooms and critical utilities, with trending that shows the shift.
Precise, defensible method work by consultants who've done it in the lab, from method suitability to virology method development and ATMP bill of testing.
New method, new site, new instrument, validation and transfer only work if they're planned properly. We design protocols, execute studies and document outcomes that stand up to regulatory scrutiny.
A lab is only as good as its qualification. We cover the lifecycle from laboratory design through URS, IQ, OQ and PQ to decommissioning, with validation protocols and reports that survive an audit.
Compliance is an interpretation of GMP, GLP and Pharmacopeia requirements applied to how your site actually works. We help you get it right, defend it to inspectors, and train your team on it.
Tell us what you're working on, we'll get back to you with a plan that fits.
