Development and validation of control methods for medicinal products and feed additives
Quality control methods are part of the regulatory documentation for a medicinal product or feed additive and are reviewed at registration. We develop methods for the specific product composition and confirm their suitability through validation.
What the work includes
- Method development: selection of sample preparation and analysis conditions for determining active substances and impurities in a specific dosage form or additive.
- Validation: specificity, linearity, analytical range, accuracy, repeatability, intermediate precision, robustness.
- Method transfer: reproduction of the manufacturer's methods in our laboratory with confirmation of the results.
- Documentation: the method text for the regulatory documentation and a validation report for the registration dossier.
When it is needed
- Development of a new medicinal product or feed additive.
- Expert comments on the control methods in the registration dossier.
- A change in composition, excipients or active substance manufacturer.
- Transfer of manufacturing or quality control to another site.
How we work
- Analysis of the product composition and quality control requirements.
- Selection of analysis conditions and preliminary testing.
- A validation protocol with acceptance criteria.
- Validation testing and preparation of the report.
Timing and cost
The timing depends on the complexity of the matrix, the number of analytes and the availability of reference standards. The cost is calculated individually after analysing the product composition.
Why choose us
- Experience: more than 20 years of work with veterinary medicinal products and feed additives and over 10,000 completed studies.
- In-house laboratory: 170 units of analytical and test equipment, including chromatography–mass spectrometry.
- Full cycle: studies, laboratory analysis and registration dossier preparation in one company, with no time lost passing data between contractors.
- Transparency: an agreed plan and timeline, with interim results as the work progresses.
How to order
To get a quote and agree on the study design, contact Neurometrix specialists by phone at +7 903 613-00-79 or send a request to info@neirometrix.ru. We prepare a commercial proposal within two business days.
Frequently asked questions
How does this service differ from bioanalytical method validation?
Bioanalytical methods determine a substance in biological matrices such as blood, tissues or milk and are needed for pharmacokinetics and residue depletion studies. Quality control methods determine the active substances and impurities in the product or feed additive itself and are part of the regulatory documentation.
Can the manufacturer's method be validated without developing a new one?
Yes, if the method works. We transfer and validate it in our laboratory and suggest improvements if problems are found.
Which validation parameters are mandatory?
The set of parameters depends on the purpose of the method: for an assay, specificity, linearity, accuracy and precision; for an impurity test, also the limits of detection and quantification.
Do reviewers accept validation reports from your laboratory?
Reports are prepared according to EAEU requirements for the registration dossier and include all the raw data needed for expert evaluation.