SU BioMedicine and Diapharm collaborate to register and market high quality Chinese Medicine in Europe Zeist (NL), Münster (DE), 04/17/2015 – SU BioMedicine and Diapharm have signed a strategic collaboration agreement for bringing Chinese Medicine faster and more widely spread into the EU market. Both companies have already been managing marketing authorisation processes for Traditional Chinese Medicines (TCM) in European countries. Together, they will become the leading party for registration and distribution of TCM in Europe. "Dedicated to the improvement of health care, SU BioMedicine is proud to have Diapharm as strategic partner to accelerate the introduction of high quality products for cure and care into the European market", said Jan van der Greef, PhD, CEO of SU BioMedicine. more >>
Dr Serap Açikgöz is new head of laboratory at Diapharm Analytics Oldenburg (DE), Münster (DE), 03/03/2015 – Dr Serap Açikgöz took over as head of the laboratory team at Diapharm Analytics GmbH in late February 2015. The service laboratory of Diapharm (www.diapharm.com) supports pharmaceutical companies in analytical quality control. In addition to stability and batch release testing, the company also provides method development and method validation services to ensure the quality of Diapharm clients’ medicinal products. more >>
Clinical studies to strengthen OTC products Trier, Münster (DE), 03/02/2015 – A new provider of clinical studies and strategic consulting has entered the field to revolutionise the market for over-the-counter (OTC) medicines and related products. Orange OTC Research (www.orange-otc.com) is the first clinical research organisation (CRO) to focus specifically on consumer healthcare in Europe. The company wants to become an initiator of “new, intelligent, scientifically supported product claims”, as co-founder Dr. Stefan Sandner emphasises. more >>
Changes to senior management at Diapharm Münster (DE), 12/19/2014 – Pharmaceutical service provider Diapharm is restructuring its senior management. Ralf Sibbing will continue as sole General Manager. Martin Vortkamp will leave the company by mutual agreement. Diapharm founder Dr. Stefan Sandner cited a difference in opinion regarding the strategic focus of Diapharm as a leading service provider and consulting firm for the consumer healthcare and pharmaceutical industry as the reason for the decision. Martin Vortkamp joined Diapharm in 2009 and held a variety of positions at the company before being named Co-General Manager in 2012. more >>
Pharmaceutical service provider opens representative office in Shanghai: Diapharm assists in EU registration of Chinese medicine Shanghai (CN), Chengdu (CN), Münster (DE), 07/03/2014 – On 1 July, Diapharm (www.diapharm.com) has opened its representative office in Shanghai in reaction to a surging demand for pharmaceutical consultancy services in China. Diapharm helps pharmaceutical companies to obtain drug approval in Europe and assists them in quality assurance. “We will advise and assist Chinese companies as they make their way to Europe and also support European companies that purchase active ingredients or finished products from China and that may require assistance in auditing their suppliers,” Ralf Sibbing, general manager of Diapharm, explains. more >>
Diapharm implements European GMP guidelines in China Münster (DE), London (UK), Ningbo (CN), 12/20/2013 – Pharmaceutical service provider Diapharm (www.diapharm.com) is increasing its business activities in China: Diapharm has now implemented a “European” quality management system for Neptune Pharma Ltd (www.neptunepharma.com) in their Joint Venture Partner’s factory in Ningbo, Zhejiang Province. And it has done so successfully: The veterinary medicinal product Trident 500mg/g Powder for Suspension for Fish Treatment (www.trident-50.com), is manufactured onsite under EU GMP standards. Trident has Marketing Authorisations in the UK & Norway to combat fish lice. It is set to hit the market in December 2013. more >>
Indication instead of a health claim: Diapharm makes probiotic product market-ready Münster (DE), 10/07/2013 – Pharmaceutical service provider Diapharm (www.diapharm.com) has developed a marketable probiotic medical device. The hard capsules with Lactobacillus johnsonii EU1 are used for the regeneration of the mucosal function of the small intestine, e.g. due to persistent non-specific diarrhoea or due to antibiotic-induced diarrhoea. The probiotic product is now available in Belgium under the brand of a large pharmaceutical company. Diapharm is currently searching for suitable licensing partners in other EU member states or is in negotiations regarding market introduction. more >>
Chinese Chamber of Commerce for pharmaceuticals visits Münster Beijing (CN), Shanghai (CN), Münster (DE), 09/24/2013 – Pharmaceutical service provider Diapharm (www.diapharm.com) is opening a branch office in China in 2014. Ralf Sibbing, managing director of Diapharm, announced the decision during the visit of Dr Xu Ming, the vice president of the Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), to Münster. Dr Xu, who is the representative of 2,400 Chinese pharmaceutical companies, met with the Mayor of Münster, Markus Lewe, among others on Thursday (19 September). Xu Ming made the trip to Münster to hold talks with pharmaceutical companies, which, apart from Diapharm, also included Wessling, the Altenberge-based laboratory services corporate specialist, and pharmaceutical auditor blue inspection body GmbH from Münster. more >>
For the first time, French regulatory authority ANSM approves a traditional, plant-based combination medicine: Dormicalm Paris (FR), Monaco (MC), Münster, Oldenburg (DE), 11/09/2012 – For the first time the French regulatory authority, Agence nationale de sécurité du médicament et des produits de santé (ANSM), has registered a traditional plant-based combination medicine. The product is presented as a coated tablet, with the three active substances Valerian, Passionflower and Melissa. ANSM granted the indication: for the relief of mild nervous tension and sleep disorders („Médicament traditionnel à base de plantes utilisé pour soulager une tension nerveuse légère et les troubles du sommeil. Son usage est réservé à l’indication spécifiée sur la base exclusive de l’ancienneté de l’usage“). The medication was developed by pharmaceutical provider Diapharm (www.diapharm.com), and is brought to market by FORTÉ PHARMA, Monaco, under the brand name Dormicalm. more >>
Egyptian Ministry of Health invites Diapharm to exchange knowledge Cairo (EG), Münster (DE), 10/11/2012 – At a 3-day workshop in Cairo, pharmaceutical service provider Diapharm (www.diapharm.com) presented the European regulations on medication demarcation areas to representatives of the Egyptian Ministry of Health. Currently, Egypt is revising its legislation regarding medical products, nutritional supplements and self-medication products and is considering, at least partially, taking into account EU legislation. The objective is to improve the availability of safer products. more >>
Diapharm to conduct bundled GMP audits for DSM Kaiseraugst (CH), Linz (AT), Münster (DE), 09/07/2012 – 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. more >>
A first for Portugal: Diapharm obtains registration for a traditional medicinal product with Agnus Castus Lisbon (PT), Münster, Oldenburg (DE), 06/22/2012 – 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. more >>
Pharmaceutical service provider Diapharm trading under a new name Münster (DE), Oldenburg (DE), 05/09/2012 – 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. more >>
Diapharm strengthens team for batch releases and pharmaceutical technology with Dr. Alwin Sobe Bielefeld (DE), Münster (DE), 01/17/2012 – 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. more >>
Diapharm to raise international awareness of country-specific traditional medicines London (UK), Münster (DE), 11/14/2011 – 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. more >>
Pharmaceutical service provider expands its borders: Diapharm opens office in Austria Vienna (AT), Münster (DE), 10/17/2011 – 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. more >>
Diapharm expands its Regulatory Affairs division: Petra Kist and Dr Stefanie Zumdick join the team Oldenburg (DE), Münster (DE), 09/21/2011 – 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. more >>
Diapharm adds Anja Kapelski to its GMP and Quality Management consultancy team in Bielefeld Bielefeld (DE), Münster (DE), 07/12/2011 – 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. more >>
Austria and United Kingdom approve traditional herbal medicinal product for prostatic hyperplasia London (UK), Vienna (AT), Münster (DE), 06/20/2011 – 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. more >>
Drug manufacturers discuss herbal products London (UK), 04/18/2011 – "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. more >>
Diapharm registers the first traditional herbal medicinal product containing St John’s Wort and Black Cohosh London (UK), Münster (DE), Oldenburg (DE), 02/10/2011 – 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). more >>
Diapharm: Dr André Welp is the new Product Manager for in vitro diagnostic medical devices Lübeck (DE), Münster (DE), 01/27/2011 – 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). more >>
Sabine Cartellieri and Monika Heistermann are new additions to the advisory team for health foods at Diapharm Münster (DE), 01/21/2011 – 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. more >>
