Current press releases

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DSM Nutritional Products and DSM Pharmaceutical Chemicals have mandated Diapharm GmbH to carry out bundled audits on the production of numerous vitamins, medical pharmaceuticals and fatty acids in compliance with the European Guide to Good Manufacturing Practice (GMP). The arrangement will allow the company to more efficiently structure the regularly required GMP audits. In the coming weeks, pharmaceutical service provider Diapharm will organise monitoring of the manufacturing processes of DSM production sites in Grenzach (Germany) and Dalry (UK). The auditing process began at DSM Pharmaceutical Chemicals in Linz (Austria) on September 4th and 5th, 2012.

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Pharmaceutical service provider Diapharm (www.diapharm.com) has now also paved the way for traditional herbal medicinal products in Portugal. The Portuguese National Authority for Medicines and Health Products (INFARMED) has granted a second registration for a traditional medicinal product. “Historically, this type of registration is unusual for Portugal, and it is a sign that traditional herbal medicinal products for self-medication are gaining increasing recognition across Europe,” explains Dr. Rainer Kolkmann at Diapharm. The tablet containing Agnus Castus extract has been approved by the Portuguese authorities for the treatment of premenstrual symptoms. However, Diapharm will not be marketing the product itself. Instead, the company plans to license out the registration: “We are a service provider, not a manufacturer,” explains Dr. Rainer Kolkmann.

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It is still the case that not all herbal products used in the UK for medicinal purposes have been licensed as medicinal products. “A year after the end of the transitional period on 30 April 2011, many manufacturers have still failed to upgrade their products to medicinal product status. As a result, these products are still not subject to the quality and safety requirements which are important for improving patient safety,” explains Dr. Sven Oliver Kruse from the medicinal product laboratory at Diapharm (www.diapharm.com). Diapharm has offices in the UK, Germany, Austria and Romania, and one of the company’s services is to test and develop herbal medicines (THMPs), food supplements and medical devices.

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Pharmaceutical service provider Diapharm (www.diapharm.com) has undergone a corporate restructuring. Previously separate legal entities, the companies Diapharm Regulatory Services GmbH, Diapharm GmbH and Hälsa Pharma GmbH have now merged to form Diapharm GmbH & Co. KG. The company’s founder, Dr. Stefan Sandner, remains the general partner of the new company. He founded Diapharm in 1988 as a specialist consultancy for regulatory affairs. In just under 25 years, the company has now grown into an international service provider, with offices in Bielefeld, Bucharest, London, Lübeck, Münster, Oldenburg and Vienna.

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With its wound spray Granulox, SastoMed GmbH has recently brought a new medical device to market. It improves oxygen supply to chronic wounds, using haemoglobin as the transporter. SastoMed has engaged Diapharm (www.diapharm.com) to perform the certification of the Class III medical device, and the outcome has been a great success: only 16 months elapsed between Day 1 and the granting of an EU-wide CE mark. This period of time was much less than originally expected.

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Pharmaceutical service provider Diapharm (www.diapharm.com) is expanding its team for GMP services with the addition of Dr. Alwin Sobe. As Senior Manager GMP Services and Qualified Person, his responsibilities will include the batch release of medicinal products for various pharmaceutical companies. Based in Bielefeld (Germany), he will also advise medicinal product manufacturers on technological issues and about Good Manufacturing Practice. Diapharm provides support within the areas of regulatory affairs, development, quality and business development to companies in the health product industry.

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Pharmaceutical service provider Diapharm (www.diapharm.com) is planning to raise the profile of traditional herbal medicinal products which have to date only been used in individual EU countries. For this reason, Diapharm has now applied in several European countries for registration of a product for migraine prophylaxis containing the active ingredient feverfew (lat.: tanacetum parthenium). “In the United Kingdom, feverfew has been used for more than 30 years for the prevention of migraine-type headaches and has since become firmly established on the market as a traditional medicine. However, it is practically unknown in countries like Spain, Sweden and German-speaking countries,” says Dr. Rainer Kolkmann at Diapharm. The objective of the THMP Directive from 2004 was precisely to harmonise long-established traditional medicines throughout Europe. Diapharm currently has more than 20 dossiers and registrations for traditional herbal medicinal products in its portfolio and transfers marketing rights and approvals to medicinal product manufacturers across Europe....

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Pharmaceutical service provider Diapharm ( www.diapharm.com / www.diapharm.at ) is continuing its international expansion. In October 2011, Diapharm Austria GmbH opens for business in Vienna. Diapharm advises pharmaceutical companies across Europe on approvals and the management of medicinal and consumer health products. It offers services in the fields of Regulatory Affairs, Medical & Clinical Development, Quality Management and Business Development. In addition to Germany and Austria, Diapharm also has offices in the UK and Romania.

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Pharmaceutical service provider Diapharm (www.diapharm.com) has expanded its Regulatory Affairs team this September with the addition of Petra Kist and Dr Stefanie Zumdick. Some of the duties performed by the new members will be to help support manufacturers of medicinal products and food supplements with the registration, testing and approval of their products.

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Diapharm (www.diapharm.com) is expanding its GMP and Quality Management consultancy team. From July, Anja Kapelski has joined the team at the Bielefeld office. Her role at the pharmaceutical service provider will be to plan and implement the development of GMP compliant management systems for pharmaceutical companies. Diapharm advises manufacturers of medicinal products and medical devices on quality issues and can, for example, be present at GMP inspections by regulatory authorities. Diapharm also takes responsibility for the release of medicinal products and medical devices on behalf of third parties.

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Pharmaceutical service provider Diapharm (www.diapharm.de) has obtained a THMP registration for its Urtica film-coated tablets in the United Kingdom and in Austria. The authorities have approved the traditional herbal medicinal product (THMP) containing dry extract of nettle root for the “relief of symptoms of urinary tract discomfort in men who have been told that they have an enlarged prostate (benign prostatic hypertrophy or BPH), based on traditional use only. Prior to treatment other serious conditions should have been ruled out by a doctor.” The registrations in both countries can be acquired on licence by pharmaceutical companies.

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"Patients must have confidence that herbal medicinal products are safe." These are the words used by Dr Karim Sultan, Head of Diapharm UK (www.diapharm.com), to summarise discussions at the THR holder meeting in London on Tuesday (12 April 2011). The gathering brought together approximately 20 participants, comprising manufacturers and registration holders of traditional herbal medicinal products (THRs). The group agreed to join forces in an association whose functions would include campaigning for the safety of herbal medicinal products.

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Pharmaceutical service provider Diapharm has obtained the first traditional herbal registration for a fixed combination of St John’s Wort and Black Cohosh in Europe. Both active ingredients are used to relieve the various symptoms of menopause, giving the combination a synergistic effect. One coated tablet of the medicinal product, registered by the British MHRA, contains 300 mg Hypericum extract and 6.4 mg Cimicifuga extract. "It is the first time that such a fixed combination of Hypericum and Cimicifuga has been registered in Europe as a traditional herbal medicinal product,” says Dr Karim Sultan from Diapharm UK in London (www.diapharm.com).

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Münster (Germany), 27 January 2011. New additions Sabine Cartellieri and Monika Heistermann are strengthening the advisory team for health foods and health products at pharmaceutical service provider Diapharm (www.diapharm.de). In their new roles, the two pharmacists are supporting manufacturers of dietary supplements, dietetic foods and cosmetics with product design, formulation and borderline queries, and with phrasing advertising messages. In addition to regulatory and scientific advice, they will also be providing help and support for application procedures and assessments. Diapharm performs official duties in the areas of regulatory affairs, development, quality and business development on behalf of companies in the healthcare industry.

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With effect from January 2011, Dr André Welp has joined the Medical Device Team at pharmaceutical service provider Diapharm (www.diapharm.com). As Manager of Regulatory Affairs, the qualified biotechnology engineer will from now on be based at the Lübeck office, providing regulatory advice for developers and manufacturers of medical devices, in particular in vitro diagnostic medical devices. Diapharm provides support for companies from the healthcare industry in the areas of regulatory affairs, development, quality and business development. Diapharm can also perform legal functions, such as Safety Officer or Manufacturer in accordance with the German Law on Medical Devices (MPG).

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Of the 100 most commonly prescribed medicinal products, not even half have a patient information leaflet that is easy to read. Only four of these medicinal products have package leaflets that are very easy to understand. This is the finding of a study by the pharmaceutical service provider Diapharm (www.diapharm.com) under contract from the German Federal Institute for Drugs and Medical Devices (BfArM).

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