Nutraceuticals and phytopharmaceuticals

Nutraceuticals, dietary supplements, medical devices and phytopharmaceuticals are gaining importance as an alternative to pharmaceutical products to treat minor illnesses. The classification of these products and their regulatory requirements vary from one country to another. Comprehensive development is a good strategy to get a consistent dossier that can be submitted to the various health authorities. We can help you develop the analytical methods for characterization, stability and quality control.

On the other hand, we also offer full management of clinical studies in healthy volunteers to quantify the active ingredients absorbed in order to correlate this with the efficacy results. In this kind of studies, developing the bioanalytical methods involved is a big challenge because there is usually a low rate of absorption or there are many different compounds related with the activity, especially with products of natural origin.

CMC

Chemistry, manufacturing and control analytical services are conducted under GMP compliance. During development, some phases may be executed according to GLP at the Client's request.

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We have extensive experience performing analytical tests for APIsexcipientsintermediate productsfinished productspackaging materials and process environment samples. The most suitable method is used, according to customer specifications or the relevant Pharmacopoeias description (EP, USP, BP, JP). If non-compendial methods need to be used, we develop and validate the method from scratch or transfer the method from the manufacturer.

We have a comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, APIs, intermediate products and finished products, according to the ICH Q2 (R1) in line with Q6A and Q6B. Our methods are ready for transfer to contract-giver, in compliance with EU-GMP chapter 6, performing a comparative test, a co-validation in two sites or a revalidation.

We provide full CH studies and on-going stability programmes for third parties. These services, at the client's request, can include: method transfer, method improvement, analytical standards management, storage at different conditions, scheduling of analytical timepoints, full analysis and out-of-trend (OOT) and out-of-specification (OOS) management. These tasks are always conducted according to procedures agreed upon with the client.

We provide microbiological testing for nutraceutical and cosmetic products. Our fully equipped laboratory includes a cleanroom with airlock technology and HEPA filters for the most sensitive operations. ISO methods are implemented and validated iat Kymos laboratories in order to provide quality control services for nutraceutical and cosmetics as quickly as possible.

We provide Elemental Impurities testing using ICP-MS according to ICH Q3D and European Pharmacopoeia and USP General Chapters <232>, <233> and <2232> for drug substances, excipients and drug products, including the 24 elements listed in the ICH Q3D guideline and/or others.

Cleaning validation is a significant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for later manufacturing processes. Potential contaminants include residues of the active pharmaceutical ingredients or their related substances, and residues from the products used during the cleaning process such as solvents or detergents. This is particularly important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Bioanalysis

Chemistry, manufacturing and control analytical services are conducted under GMP compliance. During development, some phases may be executed according to GLP at the Client's request.

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We provide services of pharmacokinetics calculations and statistics for bioanalytical data coming from preclinical and clinical studies.

  • Non-Compartmental Analysis (NCA)
  • Compartmental modelling using built-in models or self-generated ones
  • Bioequivalence (AUC, Tmax, Cmax)

We use the Phoenix WinNonlin® software that has been properly validated according to guidelines for IT system validation.

We conduct bioanalysis on the active ingredients in biological samples coming from clinical studies on nutraceuticals, medical devices or phytopharmaceuticals. Moreover, we offer the comprehensive management of such studies thanks to a strategic partner for clinical activities: Ethics Committee approval, recruiting, administration to volunteers, sample collection, bioanalysis and clinical report.

We offer you our experience in studies on Percutaneous Absorption for topical semisolid drug products using vertical diffusion cells (or Franz cells) according to the EMA Draft Guideline on Quality and equivalence of topical products. Both In Vitro Release Test and In Vitro Permeation Test are available using the Hanson difussion Phoenix instrument.