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Greenaxis

  • Certification services
  • Human Medicines
  • Europe

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Lloyd's Register Quality Assurance

Logo Lloyd's Register Quality Assurance
  • Certification services
  • Human Medicines
  • North America

The Lloyd’s Register Group comprises charities and non-charitable companies, with the latter supporting the charities in their main goal of enhancing the safety of life and property for the benefit of the public and, ultimately, the environment. More »

BTTG Ltd.

Logo BTTG Ltd.
  • Certification services
  • Human Medicines
  • Europe

BTTG is based in the North of England. It was founded 1989 by the merger of the Shirley Institute and Wool Industry Research Association, organisations with histories stretching back 85 years. More »

mdc medical device certification GmbH

Logo mdc medical device certification GmbH
  • Certification services
  • Medical Devices
  • Europe

In 1994 the company was notified by the German Ministry of Health (Bundesministerium für Gesundheit) to the European Commission for conformity assessment procedures under the European Medical Device Directive 93/42/EEC as one of the first German entities. The Commission assigned us the identification number 0483 and listed mdc as Notified Body in the official journal. The company is not a newcomer in the medical device business. The company could build on a good experience from technical and scientific services to the medical device industry.   Our success is based on synergy and co-operation. A worldwide network of co-operation partners and most of all a high number of lead auditors and technical experts with preclinical, clinical, technical and management background in medical devices warrant the effective, high level service our clients can rely on. We share resources with other Notified Bodies and ISO 9000 registrars and contributes actively to the exchange of experience and information on a national and international basis. Moreover our experts serve in international and European standards committees and working groups of the EU Commission. The Governing Board defining our certification policy within the legal framework represents manufacturers, health professionals and test laboratories and certification bodies. We are proud that within a short time the marking CE 0483 on medical devices - indicating our involvement as Notified Body - has contributed to the international reputation of our clients and their products. In the meantime, due to the competent performance we offer, we belong to the group of Notified Bodies that have achieved a globally known name together with a high reputation. Here mdc enjoys the flexibility of a private company that is necessary to react to the needs of our customers. We understand our task as a Notified Body to serve the public health as well as the medical device industry. More »

QS-QK-Service

  • Quality management services
  • Human Medicines
  • Europe

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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 »

QMI - SAI Global

Logo QMI - SAI Global
  • Certification services
  • Human Medicines
  • North America, South America

QMI-SAI Global helps organizations manage risk, achieve certification and drive business improvement by providing training courses, registration audits, and supplier management programs. As a division of SAI Global, our extensive network of auditors is strategically located to provide better local service in any North American market and also to serve your registration needs globally. More »

Phagecon

Logo Phagecon
  • Pharmaceutical process development and validation
  • Human Medicines
  • Europe, Worldwide

PHAGECON - Pharmaceutical Services and Consulting, Ltd. is dedicated to providing quality services to the Pharmaceutical Industry across all Europe. We present a wide range of services in Regulatory Affairs, Pharmacovigilance, Medical/Scientific and Pharmaceutical Affairs enabling us to follow the life cycle of companies and their health products. Our experience and operational flexibility allow us to offer our customers an overall and customised solution to any request related to regulatory, technical and scientific affairs. Phagecon’s senior managers have work experience at National Agencies / Authorities and in the Pharmaceutical Industry holding solid expertise in activities such as: Assessment of scientific data; Centralised, decentralised, mutual recognition and national procedures; Clinical trial applications; Compiling/writing of dossiers; Classification of drugs, medical devices, cosmetics and food supplements; eCTD compilation and publishing; GMP and GDP audits; Readability/user testing; Liaison with authorities; Licensing; Medical writing; Pharmacovigilance; Pricing&Reimbursement; Promotional material review; Readability User Testing; Renewals; Regulatory intelligence and strategy; Trainning; Translations; Variations; Writing of summaries and expert reports, among many others. Our partners & customers have a competitive advantage over their competitors: they have the guarantee that all services hired will be carried out successfully, on time and will bring added value to their organisations!   Specialties Regulatory affairs, Pharmacovigilance, Medical & Scientific Affairs, Pharmaceutical Affairs (QMS, GMP, GDP), Regulatory Submissions, Strategic Planning, Project management, European coverage, Market Access, Medical writting, Readability User Testing More »

Additel

  • Pharmaceutical process development and validation
  • Human Medicines
  • North America

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COLA, Inc.

Logo COLA, Inc.
  • Certification services
  • Human Medicines
  • North America

 We are the premier clinical laboratory education, consultation, and accreditation organization. We are an independent accreditor whose practical, educational standards have a positive and immediate impact. Our services enable clinical laboratories and staff to meet CLIA and other regulatory requirements, act in accordance with Quality Systems, and provide the best possible patient care. More »

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