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SWISS-MED Pharmaceuticals

We are up-to-date company focused on manufacturing and distribution of own products for other companies in areas of development and implementing innovations in pharmaceutical and pharmacy industry.
We provide the service ranged from production on contract, packaging, logistics, registration and pharmacovigilance of pharmaceutical products to leading quality and risk management, consultancy in the area of development and distribution of pharmaceutical products, food supplements, skin cosmetics and medical devices.
Our commitment is to provide creative, flexible and customer oriented solutions of first-class quality.

Services

  1. PRODUCTION ON CONTRACT
    - We provide consultancy for Good Manufacturing Practices in accordance with valid standards on GMP, intermediation of production, guidance on pharmaceutical technologies, pharmaceutical chemistry and pharmacognosis, guidance on preparation of pharmaceutical forms.

  2. PACKAGING 
    - Design and appearance of product packaging is one of the key factors of product success or failure in the market. Packaging is the result of association of research and technology which protects each product during the process of distribution, sale and use. The meaning of packaging is also providing means of presentation, protection, identification, integration and stability of the product. Our team of experts focuses on all those factors and is ready to give advice regarding client´s needs.

  3. REGISTRATION PROCEDURES 
    - Registration of pharmaceutical/medicinal products belongs to one of most sophisticated areas in pharma industry. Our board of experts ensures the process to be in harmony with international directives and rules. This service is being applied to needs of our client to make market entrance of the product as smooth as possible. We provide national registration, mutual recognition procedure, centralization and decentralization procedures, registration changes and registration renewal in EU.

  4. PHARMACOVIGILANCE + POST-MARKETING SURVEILLANCE
    - We provide dealing during upcoming and pending registration process, dealing with grantors of licensed products in EU region, preparation of application and dossier for national and European registration procedures and subsequent communication with state agencies, support for pharmacovigilance company department, verifying Summary of Product Characteristics translations, preparation of packaging in cooperation with art graphic studio, approval for finalized graphic proposals to print packaging.
    - We provide consultancy for implementation of clinical research, launching the product regarding your local or global marketing strategy. We tend to focus on clinical research, understanding standards and principles of primary health care, mapping the benchmarking, selection of indications, providing medical support for negotiations with EMA. 
  5. DISTRIBUTION & LOGISTICS - Those two keystones increased its meaning over last year and became key area presenting „to be“ or „not to be“ for reaching the success in pharma business. To make your entrepreneur activities profitable, you need master tracking your products in the Framework of free trade within EU countries. That´s why we are here to give you advice in the terms of Good Distribution Practice.
  6. OTC & PRESCRIBED DRUGS - Our target is to mediate manufacturing and distribution of over-the-counter products and prescribed drugs tailored according to needs of our clients. Our approach reflects the demands which health care systems of 21st century have and regards its scientific and economic aspects. Central priority of this approach is patient and quality of his life based on pharmaco-economic requirements of primary and specialized health care.
  7. FOOD SUPPLEMENTS
    - With growing availability of food supplements and complementary medicine products in the market, increases requirements of state control bodies as for meeting tremendous number of directives compared with the past. The goal is to secure access of public to products which are safe, effective and are of top quality.
  8. SKIN COSMETICS
    - We provide consultancy concerning registration of cosmetic products. Legal standards differ region by region. Our advice secures harmony with valid norms. We lead you through them smoothly.
  9. MEDICAL DEVICES
    - We secure notification of medical devices and in vitro diagnostics in harmony with international standards and quality assurance. If you enter the EU market, we can be of any assistance to you with implementing ISO 13485:2003. You can consult with us application of EU directives for gaining Declaration of Conformity (CE), proper ranking of medical devices and requirements in registration process. You can find under our umbrella the support for implementation of quality management in accordance with ISO standards. We can offer you the assistance with entering products of third countries to EU market.

Contact



Office in Czech Republic
Opletalova 921/6
110 00 Praha 1


Mobirise

SWISS MED Pharmaceuticals a.s.

Společnost zapsána v obchodním rejstříku Městského soudu v Praze, oddíl B, vložka 22403.