Nutraceuticals and phytopharmaceuticals

Nutraceuticals, dietary suplements, medical devices and phytopharmaceuticals are gaining importance as an alternative to pharmaceutical products for the treatment of minor illness. The classification of these products and their regulatory requirements change from one country to another. A comprehensive development is a good strategy to get a consistent dossier valid for the submission to different Health Authorities. We can help you to develop the analytical methods for characterization, stability and quality control.

In the other hand we offer full management of clinical studies in healthy volunteers to quantify the actives absorbed in order to correlate it with the eficacy results. In this kind of studies the development of the bioanalytical methods involved is a big challange because usually there is a low ratio of absorption or there are of a lot of different compounds related with the activity, specially in case of product of natural origen.

 

CMC

Chemistry, Manufacturing & Control analytical services are executed under GMP compliance. During development phases may be executed under GLP if it is a Client's requirement.

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We have wide experience in performing analytical tests of raw materials, APIs, intermediate products, finished products, packaging 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 should be used, We perform the method development and validation from scratch or the method transfer from the manufacturer. However, if compendial methods should be employed, a suitability test or a partial validation can be acceptable.

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) and FDA guidelines and using QbD strategies to improve the results. 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 service of ICH and on-going stability programs for third parties. The services, at client's choice, 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 performed according to procedures agreed with the client.

We provide microbiological testing for nutraceutical and cosmetic products. A fully-equipped laboratory is available including a cleanroom with airlock technology and HEPA filters for the most sensitive operations. ISO methods are implemented and validated in Kymos laboratories in order to provide quality control services for nutraceutical and cosmetics in the shortest times.

We provide services of Elemental Impurities Analysis by ICP/MS according to ICH Q3D and USP General Chapters <232>, <233> and <2232>  for drug substances, excipients and drug products. We also assess on the extension of the risk analysis required in order to minimize the analytical workload.

We have a deep knowledge of spectrometry techniques such as NIR (Near Infrared) and RAMAN. Thanks to this background we have developed consultancy services to help companies to implement QbD for process development and PAT strategies for quality control and in-process control. The most extended objectives are:

  • Use of NIR & RAMAN for identification of raw materials
  • Use of NIR & RAMAN for in-process control
  • Implementation of Process Ananlytical Technology (PAT) strategy oriented to parametric real time batch release
  • Use of NIR for quantitative analysis of drug products

Cleaning validation is a relevant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for following 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 particullary important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Bioanalysis

Chemistry, Manufacturing & Control analytical services are executed under GMP compliance. During development phases may be executed under GLP if it is a Client's requirement.

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

  • Non-Compartmental Analysis (NCA)
  • Compartmental modeling 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 perform the bioanalysis of active ingredients in biological samples coming from clinical studies of nutraceuticals, medical devices or phytopharmaceuticals. Moreover we offer the full management of such studies thanks to a strategic partner for clinical activities: Ethical Committe approval, recruiting, administration to volunteers, sample collection, bioanalysis and clinical report.

We offer you our experience in studies of Percutaneous Absorption for topical semisolid drug products using vertical diffusion cells (o Franz cells) according to Chapter <725> of the Pharmacopeial Forum. Both In Vitro Release Test and In Vitro Permeation Test are offered: