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LONZA INDIA

  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Asia, Worldwide

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Histologix

Logo Histologix
  • GLP services
  • Human Medicines
  • Europe

HistologiX Ltd is a rapidly growing GLP accredited Contract Research Organisation (CRO) providing commercial services to the Pharmaceutical, Biotechnology and Academic/Healthcare industries in Histology, Immunohistochemistry (IHC), Human Tissue Procurement, Clinical Trials, Molecular Biology and Advisory Consultancy. The Company was formed in 2005 by individuals with extensive experience in regulatory and non-regulatory diagnostic and clinical histology as well as IHC. HistologiX has a suite of dedicated laboratories within BioCity a science incubator facility, based in Nottingham, UK. HistologiX is focused on providing timely and quality solutions for our clients in all aspects of their histological, IHC and human tissue requirements. We will continually work in close collaboration to achieve these aims. More »

Basi

  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Europe, South America, Asia, Australia & New Zealand, Middle East, Africa, Worldwide

. BASI LABORATORIES | Laboratórios Basi - Indústria Farmacêutica, S.A. (Portugal) Basi is a leading privately-owned Portuguese Pharmaceutical company, which initiated its activity in 1956, dedicated to the development, manufacture and marketing of medicines and other health products that have had the opportunity to register a strong growth since 2007, coupled with profound organisational restructuring and new strategic direction which aimed, among other objectives, the broadening of its product portfolio, offering today to its partners, the medical community and general population, therapeutic solutions in more than 50 different areas, meeting the highest standards of quality with the most competitive cost possible. . FAST GROWING PRODUCT PORTFOLIO Basi Labs has been committed to counting in its portfolio the most required medicines by the health system but also other high-value formulations, pursuing both established as well as first-to-file opportunities. With more than 250 pharmaceutical projects registered in 50 different therapeutic areas and a great amount in development and registration, Basi markets and distributes products in a vast number of countries, mainly in Europe, Middle East and Africa (EMEA). Our product pipeline is filled by selections from internally developed medicines (oral liquids and semisolids), in-licensed products (all dosage forms), strategic partnerships with attentive portfolio acquisitions, sustaining a broad range of established and leading molecules for the treatment of many conditions in the fields of Anti-Infectivity; Neurology; Cardiology; Respiratory; Oncology; Blood disorders; Genitourinary; Gastroenterology; Bones, Muscles and Joints; Allergy and includes a vast list of other health products such as food supplements, biocides, medical devices and dermocosmetics. . CONTRACT MANUFACTURING AND PACKAGING For over 50 years, we have been working with companies trading in pharmaceuticals (originators and generic) and other health products around the globe, expanding their product lines and providing more cost-effective alternatives for manufacturing their products. We offer excellent expertise in technical transfer of products into our facility. Basi develops and manufactures: - Oral Liquids (solutions, suspensions, syrups); - Semisolid formulations for Topical use (gels, creams, ointments, lotions, solutions, sprays) and Suppositories. In addition to these dosage forms, Basi has fully autonomous and complete manufacturing lines for outer packaging other dosage forms. . OUR SUPPORT SERVICES - QUALITY CONTROL: Basi’s Quality Control has gained international reference, being sourced by numerous international companies for its services. We perform Contract QC testing, EU QP release and Stability. - PHARMACEUTICAL DEVELOPMENT: Basi ensures efficient product development from the first laboratory formulation through to full-scale production, having fully integrated development and production processes, involving our Regulatory Affairs team during the R&D phase to ensure that regulatory aspects are considered from the outset so that registration runs as smoothly and swiftly as possible. - REGULATORY SUPPORT: Our Regulatory Affairs team helps you to clear all of the hurdles on the journey to regulatory approval. We advise on the most effective regulatory approval strategy for each individual product in each individual market – be it a medicinal product or any health product. . WE OFFER: . 1) Out Licensing + Supply cost-effective Finished Product opportunities (with state-of-the-art ready-to-fill EU CTD dossiers) for ORAL LIQUIDS and SEMI-SOLIDS FOR TOPICAL USE: . > AVAILABLE PRODUCTS (RECENTLY REGISTERED IN EUROPE): >> Oral liquids: * Paracetamol – Syrup 4%, Oral suspension 4% | Generic * Bromhexine – Syrup 0.08%, Syrup 0.16% | Generic * Carbocisteine – Syrup 5% | Generic * Ambroxol – Syrup 3%, Syrup 6% | Generic >> Semi-solids for topical use: * Terbinafine – Cream 1% | Generic * Tioconazole – Cream 1% | Generic * Clotrimazole – Cream 1%, Cutaneous Solution 1% and Vaginal Cream 1%| Generic * Isoconazole – Vaginal Cream 1% | Generic * Hydrocortisone – Cream 1% | Generic * Betamethasone – Ointment 0.1% | Generic * Diclofenac – Gel 1% | Well established use or Generic * Etofenamate – Gel 5%, Gel 10%, Cut. Spray 10%, Cut. emulsion 10% | Generic * Methyl salicylate – Ointment 6% | Well established use * Paracetamol – Suppositories 125mg, 250mg and 500mg | Well established use * Glycerol – Suppositories 0.6g, 1g, 2g | Well established use . > LATE STAGE OF DEVELOPMENT - READY FOR SUBMISSION in 2013/2014: >> Oral Liquids: * Simeticone – Oral emulsion 10,5% | Well established use * Lactulose – Syrup 66.7% | Well established use * Nystatin – Oral suspension 100000 U.I./ml | Well established use * Ascorbic acid (Vit.C) – Oral solution (drops) 100 mg/ ml | Well established use * Ibuprofen – Oral suspension 2%, Oral suspension 4% | Well established use * Acetylcysteine – Syrup 2%, Syrup 4% | Well established use * Dextrometorphan – Syrup 0.133%, Syrup 2% | Generic * Desloratadin – Oral solution 0.05% | Generic >> Semi-solids for topical use: * Diclofenac – Cutaneous spray 4% | Generic * Nimesulide – Gel 3% | Generic . 2) Contract Manufacturing and Packaging Basi offers a newly inaugurated State of the Art EU GMP approved production facility with 5000m2 dedicated to the Manufacturing of ORAL LIQUIDS and SEMI-SOLIDS with the utmost competitive costs for every market: - Oral Liquids (solutions, suspensions, syrups); - Semisolid formulations for Topical use (gels, creams, ointments, lotions, solutions, sprays) and Suppositories. In addition to these dosage forms, Basi has fully autonomous and complete manufacturing lines for outer packaging other dosage forms. . 3) Extensive quality Portfolio (>200 EU registered products) available for Partners interested in distributing and marketing our products in Africa (all continent), Middle East, C.I.S. Countries, WBC, Latin America and Australia: - Our product pipeline includes a broad range of established and leading molecules for the treatment of many conditions in the fields of Anti-Infectivity; Neurology; Cardiology; Respiratory; Oncology; Blood disorders; Genitourinary; Gastroenterology; Bones, Muscles and Joints; Allergy and includes a vast list of other health products such as food supplements, biocides, medical devices and dermocosmetics. . 4) Expert Support Services in Regulatory Affairs: Our Regulatory Affairs team helps our partners to clear all of the hurdles on the journey to regulatory approval. We advise on the most effective regulatory approval strategy for each individual product – be it a medicinal product or any health product. Our highly experienced pharmaceutical professionals: - Compile up-to-date application dossiers and registration documents acc. the latest EU directives and specifications in eCTD/NeeS; - Plan and manage National and EU registration procedures (such as MRPs or DCPs), as best suiting customer’s intentions; - Address assessment reports and deficiency letters from registration authorities; - Compile CMC (Chemistry Manufacture Control) data packages for variations; - Plan and organize bioequivalence studies in collaboration with Contract Research Organisations (CROs). . . Our main interests at the moment are: 1) Out Licensing + Supply In house manufactured products (liquid and semi-solids) all over the EU; 2) Contract Manufacturing with the most cost effective alternatives for all Liquid and Semi-solid Dosage forms; 3) Contract Manufacturing with the most cost effective alternatives for all Large Volume Parenterals (separate manufacturing plant); 4) Partnering with companies interested in Distributing and Marketing our Extensive Quality Portfolio in Africa (all continent), Middle East, C.I.S. Countries, WBC, Latin America and Australia. . .  - For the list of Products ready to Out-license all over Europe pleae click here; -  For the full list of Basi's Portfolio (more than 250 pharmaceutical products registred in EU and many more products available for other markets - please contact our BD Department - bd.basi@basi.pt). . . . . SPECIAL PROJECT being developed during 2013:   Laboratórios Basi have been recently granted Marketing Authorisation in PT, BE, BG, CZ, DE, EE, HU, LU, LV, MT, PL, RO, SI and UK ,from a Decentralised Procedure (DCP), for the generic OTC medicinal product Paracetamol, 40 mg/ml (200 mg/5 ml), Oral Suspension, and we are now starting to look for a business partner interested in marketing this product in one or the complete set of Member States involved. Using this MA Dossier Basi can also run DCP duplicates or start a National Procedure in any of the countries, as best suiting your requirements.   Please CLICK HERE for the complete Brochure of the product with the full set of characteristics, from which we would like to highlight the following characteristics: Generic OTC medicine which can be promoted through general public and health care professionals, under any Trademark desired; Formulation designed for children acceptability with sweet orange flavour; No artificial colours; EU certified 5 ml oral syringe for maximum dosage control and easy to administer (no spills); Safe strength suitable for children of all ages of the number 1 prescribed drug in paediatrics! In many EU countries this paediatric strength has an important market share, under several trademarks. The generic product we propose, besides the very attractive price, presents some new marketable features, enabling our partners to introduce in the market a very competitive product!   You are welcome to inform us on your interest in this special project. Please direct all of your queries to bd.basi@basi.pt. . . CONTACT US TODAY: Laboratórios Basi - Indústria Farmacêutica, S.A. Parque Industrial Manuel Lourenço Ferreira, lote 15 3450-232 Mortágua - Portugal Phone: +351 231 920 250 | Fax: +351 231 921 055 | Mobile: +351 914 609 741 Email: bd.basi@basi.pt URL: www.basi.pt . More »

Genau and More

  • Pharmaceutical process development and validation
  • Biopharmaceuticals
  • Europe

Compliance services for life sciences   We work together to help you optimise your approach to regulatory compliance. Our compliance work assures that you always operate according to the latest regulations and standards, while our management work assures a focus on the relevant business processes. We provide you with accurate regulatory interpretations that will allow you to form and maintain a competitive advantage based on Long term inspection readiness Fast time to market Reduced compliance costs Our core competences consist of 4 interconnected compliance services for which we provide you with business methodologies, tools, approaches and best practices, these are: Project Management Gap Analysis Validation (IT and Process) Change Management More »

The Australian Tissue Engineering Centre

Logo The Australian Tissue Engineering Centre
  • Formulation development and drug delivery
  • Human Medicines
  • Australia & New Zealand

The Australian Tissue Engineering Centre Limited (ATEC) is a national facility delivering innovative solutions in regenerative medicine. Founded by the Bernard O’Brien Institute of Microsurgery, the Australian Stem Cell Centre and the Particulate Fluids Processing Centre at Melbourne University, ATEC is strategically located in the Melbourne biotechnology hub. The Government of Victoria funded ATEC to provide GLP-standard contract testing services, and to establish quality assurance standards for engineered tissue products.  Clients have access to world-class microsurgical expertise and a wide range of tissue development, disease and wound-healing models.  Unique in vivo models for target tissue growth and expansion, based on the proprietary implantable vascularised tissue engineering chamber which provides a highly-vascularised environment, include cardiac muscle, pancreatic islet and adipose tissue development as well as oncology. ATEC’s facilities and services are available on a fee-for-service basis, or for collaborative research towards joint objectives. More »

BIOPHARM Research Institute of Biopharmacy and Veterinary Drugs

Logo BIOPHARM Research Institute of Biopharmacy and Veterinary Drugs
  • Formulation development and drug delivery
  • Biopharmaceuticals
  • Europe

We belong to the leading group of companies in the fields of R&D and veterinary drugs. With more than 45 years of tradition and based in a modern setting near Prague, the Company has established itself as an important member of the world market in pharmacological services and biologicals. The Company has developed and markets the globally used LIVACOX® coccidiosis vaccines, and at the same time it also offers a range of veterinary medicaments and feedstuffs for small domestic animals, livestock and game animals. In addition, the Company offers pharmaceutical services as well as a range of specialised studies and analyses for veterinary and human pharmacy. More »

Applied Immunology

Logo Applied Immunology
  • Academic collaboration
  • Human Medicines
  • North America, Worldwide

Applied Immunology provides research services to support the development of biological therapeutics, vaccines and diagnostics. We profile the immune system and its response to disease and treatment using the latest immunological analysis methods, supported by a regulatory strategy designed to interpret complex and evolving requirements. More »

RxCelerate

  • GLP services
  • Human Medicines
  • Europe

      RxCelerate is an out-sourced drug development platform.We can take your drug candidate and move it to IND in the shortest possible time, at the lowest possible cost without cutting corners. In fact, our experienced team will add value to your precious asset at every stage with our state-of-the art experimental paradigms. Our ‘asset-centric’ heritage gives you the confidence to trust us with your out-sourced development needs. More »

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