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Curtis Health Caps|24 January 2022

Research and Development

We offer research and development services at all stages of the production of capsules, from idea to finished product for medicinal products, medical devices, food supplements, cosmetics and veterinary products.

We offer research and development services at all stages of the production of capsules, from idea to finished product for medicinal products, medical devices, food supplements, cosmetics and veterinary products.

We offer our clients a proper identification of their needs and requirements, reliable advising based on knowledge and experience in product research and development, preparation of documentation as well as a comprehensive professional service in modern analytical laboratories.

Technology

We offer wide range of services in the field of manufacturing technology of soft gelatin capsules and liquid forms:

  • Formulation development of new products based on the latest market trends and literature
  • Modification of existing products formulations
  • Selection of raw materials of adequate quality from qualified suppliers
  • Development of technology and performing trial and pilot batches

Analytics

Experts from Research and Development department offer professional services:

  • Development and validation of analytical methods for products
  • Development and validation or implementation of analytical methods for raw materials
  • Optimization of analytical methods
  •  Transfer of analytical methods

Works listed above are conducted according to ICH guidelines, pharmacopoeial requirements and GMP regulations.

Training

For our clients, we provide training services aimed mainly for marketing departments and medical representatives; we provide individually developed topics, training also for large groups, the opportunity to learn about the technology of the forms produced in our factory, the specifics of the pharmaceutical company’s work.

Stability tests

It is a time-consuming process to manufacture a new medicinal product and place it on the market. According to the Pharmaceutical Law Act of 2 September 2011, that is in force in Poland, a medicinal product may only be placed on the market once tests have been run and complete documentation has been presented to the relevant authorities.

One of the key tests that must be performed is the drug stability test which is run once the formula and composition of the product have been developed and once its physical and chemical parameters have been tested. In order to ensure comprehensive product service, we run shelf-life tests of products conditioned in climate boxes:

  • long-term (25˚C/60%RH),
  • medium-term (30˚C/65%RH)
  • accelerated (40˚C/75%RH)

Regulatory affairs

Our Regulatory Affairs support covers various pharmaceutical forms of medicinal products, medical devices, food supplements, cosmetics and veterinary products. We also provide support with the research and development (R&D) activities, including RA service, for the products manufactured at CHC, i.e. softgel capsules and liquids, from a concept to a finished product.

Our services in the RA area include, in particular:

  • preparation of documentation for OTC switch (medicinal products)
  • pharmaceutical consulting,
  • audit of active substance or drug product documentation (dossier audit),
  • preparation of expert reports (clinical, non-clinical, ecotoxicity, PDE value as well as quality overviews),
  • preparation and modification of the product information (SmPC, Leaflet, Instruction for Use, Labelling) and Leaflet readability testing,
  • carrying out activities concerning medical devices (assessment of medical devices in terms of compliance with current EU requirements – MDR, update of technical file, provision of surveillance-related services after the marketing of medical devices (PMS, PSUR and PMCF).

We are also proud to have an expert in pharmacognosy with over 20 years experience in our team, who prepares reliable scientific opinions and reports concerning plant raw materials used in medicinal products, medical devices and food supplements.

Our laboratories

We offer research and development services at all stages of the production of capsules, from idea to finished product for medicinal products, medical devices, food supplements, cosmetics and veterinary products. We offer our clientsa proper identification of their needs and requirements, reliable advising based on knowledge and experience in product. Research and development, preparation of documentation as well as a comprehensive professional service in modern analytical laboratories.

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