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PHATOPHY

  • Pre-clinical development and testing, pre-clinical CRO
  • Human Medicines
  • Europe

Phatophy is an Independent CRO, specialized in providing high quality development services to the human and veterinary pharmaceutica/ biological companies, biotechs and academic laboratories  from proof of concept to regulatory studies throughout the whole development of your candidates, projects, products, medical devices and feed additives. Phatophy has developed expertise and excellence in different activities: • Pharmaceutical development (analytical development, quality control, stability studies) • In Life studies (pre-clinical and clinical studies) • Bio-analyses (developpment and validation) on many biological matrices (serum, plasma, tissus, urine, feaces, milk eggs,...) • Regulatory Affairs and Project Management • Quality control Phatophy is GLP (BPL) accredited by ANSES French National Agency. Phatophy has Research Tax Credit (“Crédit Impôt Recherche / CIR”) agreement for the coming years. This agreement, obtained from the French authorities, permits to the clients working with Phatophy to refund R&D expenses to their corporate taxes. Phatophy is a member of www.lyonbiopole.com network. More »

Ridepharm

Logo Ridepharm
  • Consulting - strategy and development
  • Biopharmaceuticals
  • Europe

We are an experienced consulting company for the life science industry. More »

Veritas IRB

Logo Veritas IRB
  • Clinical development and testing, clinical CRO
  • Human Medicines
  • North America, South America

With offices in Canada and Mexico, Veritas IRB offers ethics review services and risk management solutions for organizations conducting research involving humans across North America.  Our services include: Ethics Review, Consulting, Training, Data Safety Monitoring. More »

TNO Triskelion

Logo TNO Triskelion
  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Europe

Our mission is to “safeguard the quality and safety of food, drugs and chemical substances” under slogan “Confidence in your products is our mission”. TNO Triskelion thereby wants to act as consultant in the area of quality and safety by leading the way in providing smart, high-tech solutions. More »

excellent

  • Excellent services and know how, good customer care.

  • -

LCC Consulting, LLC

Logo LCC Consulting, LLC
  • Consulting - strategy and development
  • North America

LCC Consulting is an independent consulting firm that focuses on helping companies grow. More »

Hill-Rom

Logo Hill-Rom
  • Consulting - strategy and development
  • North America

Hill-Rom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, and information technology solutions. Hill-Rom’s comprehensive product and service offerings are used by health care providers across the health care continuum in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care. 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 »

Tara Innovations LLC

Logo Tara Innovations LLC
  • Formulation development and drug delivery
  • Biopharmaceuticals
  • North America

The company is a pharmaceutical strategy consultant, drug development service provider and a sales agent for API/nutraceutical products.  Our strength lies in our capability to solve difficult problems and develop strategies for product development. We specialize in characterization of small molecules, i.e., preformulation activities. We develop different types of pharmaceutical formulations (tablets, capsules, creams, ointments, gels, parenterals, nasal sprays, ophthalmic solutions) and processes.  We are involved in contract research and analytical services, contract manufacturing, drug development and validation services. We provide solutions to packaging issues.  We also assist in writing the CMC sections for regulatory filings. More »

ChemCentre

Logo ChemCentre
  • Analytical laboratory and testing services
  • Biopharmaceuticals
  • Australia & New Zealand

At ChemCentre, we offer more than quality chemical testing and analysis. Our breadth and depth of experience means we are able to look at the big picture, using our proven analytical laboratory services  to actively minimise risk for our clients. In short, we use science to protect your finances, investments, relationships and reputation. More »

Pacific Environmental Technologies, Inc.

Logo Pacific Environmental Technologies, Inc.
  • Analytical laboratory and testing services
  • Biopharmaceuticals
  • North America

Pacific Environmental Technologies, Inc. (P.E.T.I.) is a California based licensed contractor, which was formed in 1989 to provide specialty high-tech service in the area of environmentally controlled cleanroom and laboratory environments. Our engineers, designers, project managers, field technicians and commissioning & certification group are a highly experienced and specialized organization that have worked together for many years on a large number of sophisticated projects. More »

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