Laboratory
Drug Formulation Development
Pre-formulation studies, prototype formulations and analytical support for generic and new products, designed from the start to match the reference product and pass registration.
Built to matchthe reference product
The problem
A formulation that fails dissolution or stability late in development costs months and a full batch.
What we do
Pre-formulation studies, prototype formulations and analytical support for generic and new products, designed from the start to match the reference product and pass registration.
Terms and conditions apply. Read the terms
Who it is for
Manufacturers developing a generic, a new strength or a new dosage form.
What you receive
- Pre-formulation review of the active ingredient and excipients.
- Prototype formulations at laboratory scale.
- Comparative dissolution against the reference product.
- Analytical methods for assay and related substances.
- Stability study design and testing support.
- A development report you can carry into scale-up and registration.
How we deliver it
- Review of the reference product and target market.
- Development plan with milestones.
- Prototype trials and laboratory testing.
- Selection of the lead formulation.
- Stability and comparative testing.
- Development report and handover.
The value to youA formulation built to pass bioequivalence and registration, not just the bench.
Related services
Bioequivalence and Clinical Research (CRO)We plan and run bioequivalence and pharmacokinetic studies for pharmaceutical companies, from protocol design and ethics approval to clinical conduct, bioanalysis, statistics and the final study report.Bioanalytical and Drug Analysis LaboratoryLC-MS/MS method development, validation and sample analysis for drugs, metabolites and residues in biological, food, plant and environmental samples, with results issued in a signed certificate of analysis.Drug Registration and Regulatory AffairsWe prepare, review and submit registration dossiers for medicines and health products in the UAE and abroad, including US FDA registration, and follow each file until a decision is made.
Tell us about your product or your samples
We reply with the right method, a timeline and a written quotation. A non-disclosure agreement comes first if you need one.