Chemistry & Analytical Methods

In-depth knowledge of the requirements of the validation processes for pre- and post-registration analytical methods is essential for a successful completion of many of the numerous studies required for registration purposes. The analytical methods specialists at RIFCON are highly experienced in all aspects of regulatory analytical chemistry including the monitoring and assessment of method validation studies, physico-chemical property testing requirements and the handling of confidential analytical data.

Studies on residues, toxicology, environmental fate and ecotoxicology typically rely on the accurate determination of active substances and/or their metabolites in various matrices. Current EU legislation requires a full validation of the analytical methods and specifies the respective criteria. Accordingly, correctly and fully validated analytical methods and their clear reporting according to the requirements of current EU guidelines (SANTE/2020/12830, Rev.1, SANCO/3029/99, SANCO/3030/99, SANCO/825/00 and OECDENV/JM/MONO(2007)17) are fundamental to the success of any registration.

Over the years, our regulatory analytical methods specialists have gained extensive experience in assessing analytical method validation reports, monitoring analytical method validation and physico-chemical property testing studies, coordinating 5-batch analyses and writing equivalence assessment reports. We prepare the analytical methods and physico-chemical properties sections of registration dossiers in compliance with current EU legislation for the registration of plant protection products and active substances. We also evaluate and reply to authority requests, compile expert statements and devise up-to-date strategies and solutions.

Our Services

Confidential support

5-batch analysis / Equivalence assessment / Data compilation

Dossier preparation

Physico-chemical properties / Analytical methods

Dossier support

Authority requests / Expert statements

Study monitoring

Lab communication / Quotation gathering / Monitoring services / Report assessment and revision

Data analysis

Data gap analysis / CoC and GD compliance / Preliminary assessment / Cost estimation

Our Services

Confidential support

5-batch analysis / Equivalence assessment / Data compilation

Dossier preparation

Physico-chemical properties / Analytical methods

Dossier support

Authority requests / Expert statements

Study monitoring

Lab communication / Quotation gathering / Monitoring services / Report assessment and revision

Data analysis

Data gap analysis / CoC and GD compliance / Preliminary assessment / Cost estimation