Analytical characterisation, method validation, and regulatory documentation for biologics manufacturers. Built to ICH standards. Delivered without shipping your samples overseas.
Every batch characterisation, every comparability study, every method validation currently leaves the country. Samples go to Europe, Singapore, or India. Weeks pass. Costs mount in foreign currency.
And when a DGDA query or a WHO reviewer asks a follow-up question eighteen months later, the raw data sits in someone else's laboratory notebook.
Bioremedium exists to close that gap.

Figure 1 — Where the time actually goes. Illustrative day counts; replace with defensible figures before launch.
Shipping, cold chain, customs clearance, broker fees, and the cost of waiting. None of it improves the quality of your data.

Figure 2 — Market context and cost composition. Indicative figures; the 82% requires a source or removal.
No customs clearance. No cold chain risk across three borders. No waiting for a slot in an overseas queue.
Foreign CRO contracts are quoted in euros and dollars, and the exchange exposure sits entirely with you.
Raw data, chromatograms, and audit trails remain accessible when a regulator asks a question years later.
Technical discussions happen in the same time zone, in a meeting room, when a result needs interpreting.
Purity, size and charge variants, glycosylation, aggregation, and process impurities for mAbs and other biologics.
Validated to ICH Q2(R1), with reports written for regulatory submission, not internal filing.
Biosimilarity to ICH Q5E. CTD Module 3 preparation. Gap analysis against DGDA and WHO.
Hands-on capability building for your QC and process development teams.
Every engagement operates under a signed non-disclosure agreement, executed before any technical detail is exchanged.
Project teams are separated. Data is segregated at system level. Client identities are never disclosed without written permission — including on this website.
Spanning academia, industry, and international research — the three things a biopharmaceutical services company needs.

Figure 7 — Three founders, three complementary halves of the company.
Send a brief outline of what you need characterised. We respond within five working days with a scope, timeline, and indicative cost.
Get in touch