Our services
Analytical services for pharmaceutical development and release
Two service lines run on one quality system. R&D work builds and proves the method; routine work runs it batch after batch. Both are delivered with the protocols, reports and raw data your filing or release decision needs.
01
R&D Services
For products moving toward a filing. We build the analytical method, challenge it until it holds, and document it so a reviewer can follow every decision.
Typical client
Formulation R&D and API development teams preparing a dossier, or transferring a method into commercial QC.
Method Development & Validation
HPLC and GC methods developed for the product, then validated for specificity, linearity, accuracy, precision, LOD/LOQ and robustness — with protocol and report.
Forced Degradation & Stability
Acid, base, oxidative, thermal and photolytic stress to demonstrate the method separates degradants from the active. Mass balance and peak purity assessed.
Dissolution Method Development
Medium, apparatus and sink-condition selection, profile generation across time points, and comparison of test against reference required.
Pharmacopeial Feasibility
Verification that an IP, USP, BP or EP monograph method performs on your product and in our lab before you commit to it.
SOP, STP, Protocol & Report Writing
Documentation written to the structure reviewers expect — standard test procedures, validation protocols, study reports and supporting SOPs.
ICH Stability Studies
Long-term, intermediate and accelerated condition studies to ICH Q1A, with defined intervals, a written protocol and a trend-analysed final report.
02
Routine Analysis
For products in production. Testing against an agreed specification, on an agreed turnaround, reported with the data behind every number.
Typical client
QC and QA teams at formulation, API and contract manufacturing sites releasing commercial batches.
Batch Release & COA
Full specification testing on finished product or API, issued as a Certificate of Analysis with supporting chromatograms and calculations.
Assay & Related Substances
Quantification of the active and its impurities by HPLC against qualified reference standards, reported to the specification limits.
Residual Solvents — GC-HS
Class 1, 2 and 3 solvent determination by headspace gas chromatography, to the limits your monograph or ICH Q3C sets.
Dissolution & Disintegration
Routine dissolution profiles and disintegration testing on tablets and capsules against the release specification.
Physical & Wet Chemistry
Water content, loss on drying, pH, sulphated ash and titrimetric assay — the supporting tests a full specification requires.
ICH Stability Studies
Ongoing commitment and annual stability programmes run alongside routine release testing, on the same documented methods.
What you receive
Every engagement ends in documents you can use
A result on its own is not useful. What makes analytical work defensible is the paperwork around it — the method it followed, the standard it was measured against, and the review it passed.
Certificate of Analysis
Results against specification, signed and dated.
Raw data pack
Chromatograms, weighings and standard details.
Validation report
Protocol, results and conclusion, filing-ready.
Standard test procedure
The method itself, transferable to your QC lab.