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Complya Asia

  • GMP audit services
  • Human Medicines
  • Asia

Complya Asia provides expertise and guidance to help you meet your international cGMP compliance requirements. Working with your in-house experts, our Quality Assurance specialists will ensure your Quality Systems and facilities meet the current standards for US FDA, European EMA, and other international organizations, including ICH and WHO. Complya Asia is a consulting company registered in China with headquarters in Suzhou (near Shanghai). We provide consulting services in the area of Quality Assurance and cGMP compliance. Our founders have an average of more than 20 years experience in pharmaceutical and medical device QA and cGMP operations. We have worked with numerous international and domestic companies throughout the US, Europe, and Asia who are developing therapeutic, vaccine, diagnostic and medical device products. Call us for all of your Quality Assurance needs. We welcome your questions and look forward to discussing your challenges. Complya Asia Co., Ltd. Suzhou, China +86 134 7272 7417 swheelwright@complya-asia.com More »

Flavine

Logo Flavine
  • GMP audit services
  • Biopharmaceuticals
  • Europe, North America, Asia

In a world where the healthcare revolution is increasingly transforming our lives, Flavine is leading the expansion of sourcing activities for its customers. For more than 35 years, we are thriving to add value to the business of both suppliers and customers by locating and developing quality manufacturers and opening up new markets. More »

BimSiframGroup, Inc.

Logo BimSiframGroup, Inc.
  • GMP audit services
  • Biopharmaceuticals
  • Europe, Asia

BimSiframGroup (BSG) is a Sino-French company specialised in the production and distribution of plant extracts, active ingredients, chemical intermediates and biochemical products. 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 »

IBI Lorenzini

  • Pharmaceutical process development and validation
  • Biopharmaceuticals
  • Europe

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 »

ITPL

Logo ITPL
  • GMP audit services
  • Biopharmaceuticals
  • North America

ITPL labs Inc is a contract laboratory testing, training and consultation services since 1993. ITPL is FDA inspected and registered, and also DEA licensed. ITPL provides full pharmaceutical and food testing lab service at all stage of product development and as well as raw material. We specialize in the method development, validation and stability testing study for pharmaceutical product, cosmetic products, nutritional products and raw material. Our technical staff has scientific degrees and industrial background. Our Quality Assurance staff monitors compliances to laboratory internal SOPs and Certificate of analysis for release batch. Our technical staff designs the protocol for work and prepares the report for statistical analysis results. ITPL has added two new dimensions of pharmaceutical services to our customers:   1.   A professional and Comprehensive cGMP Training Program tailored to our customer needs and available as in-house at the customer site and/ or as public workshops.   2.   Auditing for cGMP compliance Services worldwide in accordance with the latest guidelines for API manufacturer, Toll manufacturers, excipients and packaging materials suppliers. In addition we help and provide technical support in qualifying facilities to obtain FDA and Euro regulatory approvals More »

TMQA (Tower Mains Quality Assurance)

Logo TMQA (Tower Mains Quality Assurance)
  • GMP audit services
  • Human Medicines
  • Europe

TMQA provides worldwide audit, consultancy and training support in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP), Medical Devices, ISO standards and non-regulated research. More »

QuadPharma

Logo QuadPharma
  • Contract manufacturing, filling and packaging
  • Human Medicines
  • North America

QuaDPharma is a GMP contract drug manufacturing company delivering high value to clients in terms of flexibility, responsiveness and relationships heavy on collaboration. Specialties in semi-solids, solids, small-molecules, large molecules, packaging, analytical method development and process optimization drive an engine that continually satisfies the needs of our clients. Founded in 2010 by President & CEO Stephen A. Panaro, Ph.D. QuaDPharma, Inc. was designed from the beginning to serve the needs of the pharmaceutical industry that relates to small-scale pre-commercial and commercial manufacturing. Dr. Panaro has synthesis expertise in Drug Discovery and Pilot Plant scale-up and has used these skills throughout his tenure at APP Pharma and Contract Pharmaceuticals Ltd. More »

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