One of the pillars of our business is pharmaceutical consulting, as part of which we carry out eg. product assessment in terms of correct legal qualification or active substance assessment in terms of the possibility of changing the availability category of a medicinal product from Rx to OTC. Such activities are intended to support both the process of development of medicinal products, food supplements and medical devices, and the development of already existing product groups within Line Extension. We offer our clients: proper identification of their needs and requirements, reliable, knowledgeable and experienced consulting in the area of research and product development, preparation of expert reports, preparation of documentation. As part of our pharmaceutical consulting service we offer support in the development of new products – from concept to market launch.
Pharmaceutical consulting stages
As part of the pharmaceutical consultancy service, we offer our clients:
product assessment in terms of the correct legal classification: medicinal product, medical device, foodstuff (assessment of product registrability),
assessment of the substance in terms of the possibility to change the availability category of the medicinal product from Rx to OTC (Switch),
optimal choice of registration route for the medicinal product (generic or WEU, TU),
assessment of the product for possible exemption from the need to conduct a bioequivalece clinical trial (Biowaiver report).
Pharmaceutical consulting conducted by our experts covers various activities, including:
conducting detailed market and competition analyses, reviewing registry databases,
design, which allows a rational decision to implement the product,
support in the preparation of product labeling, notification of food supplements, obtaining the FSC document (Free Sale Certificate),
support in the development of technical documentation for medical devices and certification of medical devices, as well as support in carrying out post-marketing activities PMS (Post-Marketing Surveillance), PMCF (Post-Marketing Clinical Follow-up), and the service of the Person Responsible for Regulatory Compliance (PRRC) for Medical Devices,
support in the development of registration documentation for medicinal products, support in the process of registration of a medicinal product in the national and European procedures.
As part of comprehensive pharmaceutical consulting services, our clients receive a market analysis allowing them to create new products or improve existing ones, while taking into account market trends and consumer needs. Our consulting services are guaranteed by our team of qualified employees with many years of experience in the area of notification of food supplements, certification of medical devices, registration of medicinal products and preparation of documentation of a change in the availability category of a medicinal product – switch OTC.
Wysogotowo ul. Batorowska 52 62-081 Przeźmierowo POLAND District Court for Poznań - Nowe Miasto and Wilda in Poznań, the 8th Commercial Division of the National Court KRS 0000871229 NIP 781-00-41-371 Share capital: 36 100 000PLN