Stage 01
Product selection
- Patent and exclusivity check
- API sourcing and DMF review
- Market and price modelling
Development pipeline
Five stages, and where the cohort stands
These stages are sequential — a programme cannot enter one until the previous is signed off. The bars show how much of the current cohort has cleared each stage.
Stage 02
Formulation development
- Prototype trials at 1/10 scale
- Comparative dissolution profiling
- Excipient compatibility studies
Stage 03
Analytical & stability
- Method development and validation
- Accelerated 40 °C / 75% RH
- Long-term 25 °C / 60% RH
Stage 04
Bioequivalence
- Pilot study in fasted subjects
- Pivotal study at a partner CRO
- Statistical review of Cmax and AUC
Stage 05
Filing & scale-up
- CTD dossier compilation
- Exhibit batches at full scale
- Regulatory queries and approval
Capability
What the laboratory can do in-house
Formulation development
Immediate-release and sustained-release oral solids, bilayer tablets, dispersible and chewable presentations, dry syrups, suspensions, and semi-solid topicals. Prototypes are trialled at one-tenth of commercial scale before any exhibit batch is planned.
Analytical development
Method development and validation to ICH Q2 principles, forced degradation and impurity profiling, comparative dissolution profiling against the reference product across pH 1.2, 4.5 and 6.8 media.
Stability programme
Accelerated conditions at 40 °C / 75% RH and long-term at 25 °C / 60% RH, with intermediate conditions where the accelerated data requires it. Chambers are mapped, alarmed and logged continuously; every marketed product carries at least one batch per year in the ongoing programme.
Regulatory affairs
CTD and ACTD dossier compilation, country-specific registration files, artwork and leaflet preparation in local languages, and response handling for regulatory queries.
Bioequivalence
Studies are run outside, reviewed inside
Clinical work is placed with accredited contract research organisations. We define the protocol, supply the test and reference product, and review the data ourselves before it goes into a dossier.
A pilot study in a small fasted cohort establishes whether the formulation is worth taking further. Only then is a pivotal study commissioned, sized to the variability seen in the pilot.
Acceptance is the standard 80–125% confidence interval on Cmax and AUC against the reference product. Where a study fails, the formulation goes back to Stage 02 rather than being re-run in the hope of a different result.