Delta Med AJANS VE DİL HİZMETLERİ LİMİTED ŞİRKETİ FOOD SUPPLEMENT and COSMETICS
ABOUT US DeltaMed Ajans ve Dil Hizmetleri Ltd. Şti. is a company established with the purpose of providing translation and medical research services as well as regulatory consulting to the pharmaceutical industry and of delivering the best performance with expert colleagues within the most convenient time frame. Established in 2007 on the basis of our longstanding experience, our company is currently cooperating with top companies in the Turkish pharmaceutical market. DeltaMed Ajans continues to stand behind its services by adopting the policy that companies doing the right planning, adopting the correct financial and managerial decisions, setting the correct goals, cooperating with the right partners and putting these principles into practice are set to be successful in the industry. We have achieved yet another objective in 2014 and obtained ISO 9001-2008 quality management systems and TS EN 15038 Quality Management in Translation and Translation Service Certification certificates we speak the same language as you... EN 15038:2006
SERVICES RELATING TO COSMETIC PRODUCTS www.deltamedajans.com
Company Registration Company registration with the UTS and where applicable, EBS systems Assignment of the responsible qualified persons Product Registration Creation of UTS system records for existing products already registered with the EUP system (for each group comprising 5 products) Performance and review for regulatory compliance of the Cosmetic Product Formulation process Performance of the product nanomaterial process if applicable Cosmetic Product Registration Preparation of Usage Instructions, Labeling and Packaging Accomplishment of the Cosmetic Product Application process Making required updates to the application based on deficiency reporting sent by the Medicines and Medical Devices Agency we speak the same language as you...
Product Information Dossier Preparation Dossiers are prepared in accordance with the legislative requirements of the Medicines and Medical Devices Agency Product Safety Assessment Reporting Reports are issued by competent specialists who received the required training in accordance with relevant legislation. Review of Dossiers Prior to Inspection The prepared dossiers are checked by our specialists for compliance with current legislation Product Information Dossiers must be submitted in no later than 3 business days upon request by the Ministry Delivery deadlines are subject to mutual discussion depending on specific products. www.deltamedajans.com
REGULATORY SERVICES FOR FOOD SUPPLEMENTS we speak the same language as you...
Dossier preparation and follow-up Rectification of deficiencies, and Obtaining label approvals Food Supplements Our team of specialists provide the following services required for the approval of Food Supplements by the General Directorate for Food and Control of the Ministry of Agriculture: Dossier Preparation in Accordance With The Legislation Compliance check of the product name and brand Compliance check of active substances and quantities with the food supplements legislation Compliance check with the list of botanicals, list of restricted substances, and further legislation Compliance check supplements and quantities with the food supplements legislation Preparation of the percent composition list Preparation of the specification certificate Supply of technical support for the provision of documents requested by foreign organization, and Registration of the Company and Products in the Food Safety Data System. Once the dossier is prepared and submitted to the Province Directorate of Agriculture, we keep track of the process, answer any inquiries regarding possible deficiencies, and conduct the negotiations with specialists. www.deltamedajans.com
Label Approvals Depending on individual product type, obligatory label information is prepared in accordance with the relevant label regulations. Nutritional statements are provided in compliance with the relevant legislation upon request Preliminary applications for label approvals are submitted. Required corrections are made upon communication with specialists during the course of approval we speak the same language as you...
Any proceedings with the Province Directorate of Agriculture on your account are subject to a notarized letter of authorization. Application fees/duties imposed by the Ministry of Agriculture are covered by your Company Package design is provided by your Company. Technical particulars to be displayed on the package will be provided by us. www.deltamedajans.com
OUR CERTIFICATES we speak the same language as you...
Abdi İbrahim İlaç San. ve Tic. A.Ş. Abdi İbrahim Otsuka İlaç San. Ve Tic. A.Ş. Actavis İlaçları A.Ş. Actelion İlaç Tic. Ltd. Şti. Adam Farma İlaç Sanayi Tic. Ltd. Şti. Adeka İlaç Sanayi ve Ticaret A.Ş. Alcon Laboratuarları Tic. A.Ş. Ali Raif İlaç San. A.Ş. ALK İlaç ve Alerji Ürünleri Tic. A.Ş. Amgen İlaç Ticaret Ltd. Şti. Angelini İlaç San. Tic. A.Ş. Aprimed İlaç Ve Kim. Ür. San. Tic. A.Ş. Astellas Pharma İlaç Tic. ve San. A.Ş. AstraZeneca İlaç Sanayi ve Tic. Ltd. Şti. Aurobindo İlaç Sanayi ve Tic. Ltd. Şti. Avicenna Farma Dış Tic. ve Paz. A.Ş. Bausch & Lomb Sağ. Ve Optik Ür. Tic. A.Ş. Bayer Türk Kimya San. Tic. Ltd. Şti. Berka Medikal A.Ş. Berk İlaç. İth. ve Paz. A.Ş. Berko İlaç A.Ş. BFR Gıda Tekstil San. ve Tic. A.Ş. Bikar İlaç Sanayi ve Tic. Ltd. Şti. Bristol Myers Squibb İlaçları Ltd. Şti. Bristol-Myers Squibb İlaçları Inc. Celltrion Healthcare İlaç San. ve Tic. A.Ş. Centurion Pharma İlaç San. ve Tic. Ltd. Şti. Chiesi İlaç Tic. A.Ş. Ceva Hayvan Sağlığı A.Ş. CS Cilt Sağlığı İlaç ve Koz. Ür. Tic. Ltd. Şti. Csl Behring Biyoterapi İlaç Dış Ticaret A.Ş. Daiichi Sankyo İlaç Tic. Ltd. Şti. Dentoral Diş ve Ağ. Sağ. İl. Grçl. San. ve Tic. Eczacıbaşı İlaç Paz. A.Ş. Egis İlaçları Ltd. Şti. Embil İlaç San. Ltd. Şti. Er-Em Farma Ltd. Şti. Er-Kim İlaç Sanayi ve Ticaret A.Ş. Estee Lauder Companies Farma-Tek İlaç San. Ve Tic. A.Ş. Farmatürk İlaç San. ve Tic. Ltd. Şti. Faselis Sağlık Ürün. İth. ve İhr. Dah. Tic. Ferring İlaç Sanayi Ve Tic. Ltd. Şti. Fresenius Medikal Hizmetler A.Ş. Gekem İlaç Sanayi ve Ticaret LTD. ŞTİ. Generica İlaç San. ve Tic. A.Ş. Genesis İlaç ve Sağlık Ürünleri Ltd.Şti. Genoks Teknoloji Sağlık Tic. Ltd. Şti. Genzyme Sağ. Hzm. ve Ted. Ürn. Tic.Ltd.Şti. Gilead Sciences İlaç Tic. Ltd. Şti. Glaxosmithkline İlaçları San. Ve Tic. A.Ş. Gripin İlaç A.Ş. Guerbet İlaç San. ve Tic. A.Ş. Gürel İlaç Ticaret A.Ş. Hasbiotech İlaç. San. ve Tic. A.Ş. Helba İlaç İç ve Dış San. Tic. Ltd. Şti. Helvacızade Gıda İlaç Kim. San. ve Tic. A.Ş. Incpharma İlaç San. ve Tic. Ltd. Şti. ITF İlaç Ltd. Şti. İ.E.Ulagay İlaç Sanayii Türk A.Ş. İBSA İlaç Sanayi ve Ticaret Ltd. Şti. İlko İlaç Sanayi ve Ticaret A.Ş. İmaretçioğlu İlaç San. Ltd. Şti. İmuneks Farma İlaç Sanayi ve Tic. A.Ş. İstanbul İlaç San. Tic. A.Ş. Janssen - Cilag Ltd. Şti. Jeunesse Kozmetik Tic. Ltd. Şti. Johnson & Johnson Ltd. Şti. Kansuk Laboratuvarı San. Tic. A.Ş. Kiko Kozmetik Ürünleri Ticaret A.Ş. Konsina İlaç San. ve Dış Tic. A.Ş. Kowa Turkey Sağlık Bakım A.Ş. Kurtsan İlaçları A.Ş. Ladee Pharma Ecza Tic. Ltd. Şti. Leo Pharma İlaç Ticaret A.Ş. Liba Laboratuarları A.Ş. Lilly İlaç Tic. Ltd. Şti. Lundbeck İlaç Ticaret Ltd. Şti. Mallinckrodt Sağlık A.Ş. Mamsel İlaç San Ve Tic. A.Ş. Med İlaç San. ve Tic. A.Ş. Meda Pharma İlaç San. ve Tic. Ltd. Şti. Medfors İlaç ve Sağlık Ürünleri A.Ş. Mefar İlaç Sanayii A.Ş. Merck İlaç Ecza ve Kimya Tic. A.Ş. Mustafa Nevzat İlaç San. A.Ş. Münir Şahin İlaç Sanayi ve Tic. A.Ş. Nativet Gıda Sanayi Ticaret A.Ş. Nobel İlaç San. ve Tic. A.Ş. Novartis Sağlık Gıd. ve Tar. Ürn. San. ve Tic. A.Ş. OUR REFERENCES Novel Farma İlaç San. Ve Tic. Ltd. Şti. Octamed Sağlık Ürünleri San. Ve Tic. A.Ş. Omega Pharma Kişisel Bakım Ür. San. Tic. Ltd. Şti. Onko İlaç San. ve Tic. A.Ş. Onfarma İlaç İnş. Tıbbi Aletler San. ve Tic. Ltd. Şti. Orion Sağlık Grup Tic. Ltd. Şti. Oro İlaçları San. Tic. A.Ş. Pfe İlaçları A.Ş. Pfizer İlaçları Ltd. Şti. Phibro Hayvan Sağlığı Ürünleri San. ve Tic. A.Ş. Pierre Fabre İlaç A.Ş Polpharma Sağlık Ürünleri San. ve Tic. A.Ş. Reformed İlaç Sanayi ve Ticaret A.Ş. Resmed Sağlık Ürünleri ve Tekstil San. Tic. Ltd. Şti. Roche Müstahzarları San. A.Ş. RPFarma İlaç ve Kozmetik San. Tic. Ltd. Şti. Sandoz İlaç San. ve Tic. A.Ş. Sandoz Syntek İlaç Hammaddeleri San. ve Tic. A.Ş. Sanofi Aventis İlaçları Ltd. Şti. Sanofi Sağlık Ürünleri Ltd. Şti. Santa Farma İlaç San. A.Ş. Say İlaç Ltd. Şti Servier İlaç ve Araştırma A.Ş. Smf İlaç Kozmetik Sağ. Gıda San. Ve Tic. A.Ş. Stallergenes İlaç Promosyon Ltd. Şti. Synageva BioPharma Corp. Türkiye İrt. Bür. Takeda İlaç Sağlık San. Tic. Ltd. Şti. Terra İlaç ve Kimya San. Tic. A.Ş. Teva İlaçları Sanayi ve Ticaret A.Ş. Thea Pharma İlaç Ticaret Ltd. Şti. Total Laboratuvarları İlaç San. ve Tic. Ltd. Şti. Türk İlaç ve Serum San. A.Ş. Türk Philips Tic. A.Ş. Ucb Pharma A.Ş. Ufsa İlaç Sanayi ve Ticaret AŞ. Ulagaylar İlaç San. Ve Tic. A.Ş. Umay İlaç Sanayi Ticaret A.Ş. Vilsan Veteriner İlaçları Tic. San. A.Ş. Vimar Gıda Tarım ve Hayvancılık San.Tic. A.Ş. Vitalis Sağlık Ürünleri Danışmanlık ve Tic. Ltd. Şti. World Medicine İlaçları Ltd. Şti. Zet Farma Lojistik Hizmetleri Ltd. Şti. Zoetis Hayvan Sağlığı Ltd. Şti. www.deltamedajans.com
Delta Med AJANS VE DİL HİZMETLERİ LİMİTED ŞİRKETİ Eski Üsküdar Yolu Caddesi. Bodur İş Merkezi. Kat: 6 D: 23-24 Ataşehir / İstanbul Tel : +90 216 577 20 02 Fax : +90 216 577 20 80 Web : www.deltamedajans.com Mail : info@deltamedajans.com Versiyon:01ENG