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Ethical GmbH

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

Ethical eAdjudication®  Clinical Endpoint Adjudication made simpler, effective & GxP compliant with a focused Cloud Software Service.  Ethical supports Endpoint Adjudication with a user-friendly professional software solution designed to ease the daily work of Adjudication Staff and Adjudication Committees (CEC). The software is GxP / 21 CFR part 11 validated and has been designed for flexibility and completeness. A set of Software APIs allows the direct integration and data transfer with practically any other eClinical solution for Medical Record collection and assembling.  Ethical is located in Basel Switzerland and it has been founded by GM Servizi an Italian company that contributed to hundred of Clinical Trials with the design & management of CTMS, EDC, Safety Databases, Patients' Registries and Endpoint Adjudication solutions in partnership with Pharma Companies or CROs.  More »

MethodSense

Logo MethodSense
  • Quality management services
  • Medical Devices
  • Worldwide

MethodSense is a life science consulting firm with offices in the US and Europe. We guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Our services enable clients to operate more effectively during the commercialization process and beyond. From 510(k) submissions to IEC 60601-1 tables and Software Development Lifecycle Management to Quality System Management, our life science and medical device consultants have the experience to help you bring your product to market without unnecessary delay. Our services are designed to position your life science product and business operations for commercial success. We provide a complete spectrum of quality assurance, regulatory, technology and operational services to achieve commercialization success through compliance with US and international medical device, biotech and pharmaceutical regulations and standards. Our services include the following:   Regulatory Affairs: Satisfy US FDA compliance and global authorization requirements Quality Assurance: Achieve product quality standards and operational efficiency Quality Certification: Meet quality standards to bring your product to market internationally On-Call Quality Support: Reduce your business risks for noncompliance with quality support when you need it Safety Testing Management: Manage product quality and safety requirements for global and FDA compliance Technology Management: Minimize risk with compliant business and product technologies Data Integrity: Address the integrity of your data before it becomes an issue Business Operations: Ensure records, signatures and documentation are reliable Key Services Include: audit/compliance service, biopharmaceutical service, business process strategy/management, combination products service, consulting, devices service, EU related services, FDA related services, medical device service, pharmaceutical consulting, quality assurance, quality/regulatory services, quality management, regulatory services, risk assessment/risk management, strategy consulting, validation services More »

Suzhou Lixin Pharmaceutical Co.,Ltd

Logo Suzhou Lixin Pharmaceutical Co.,Ltd
  • Contract manufacturing, filling and packaging
  • Biopharmaceuticals
  • Asia

Since its inception in January 2000, the company has targeted at regulated APIs/Intermediates markets. It has built up several workshops under GMP guidelines, with complete public utilities and auxiliaries. We have also established a standard quality system and advanced quality control method, which has led us into cooperation with many world-famous companies. Orienting at international markets and insisting on the innovation of production process and patent protection, the company focuses on the research and development of both patented and generic drugs. We have developed a series of APIs including Antineoplastic drugs, Cardiovascular drugs, Nootropic drugs, Antiplatelet drugs etc. We also put emphasis on overseas dossiers submissions including DMFs, CTDs and many country registrations. All these efforts have brought us favorable feedbacks from our customers. More »

Charnley Nickols Associates Ltd.

Logo Charnley Nickols Associates Ltd.
  • GCP audit services
  • Human Medicines
  • Worldwide

We are an independent company, we provide practical, unbiased and targeted advice to achieve compliance and enhance quality. We have been successfully assisting companies worldwide for over 15 years and this is evidenced by our many long-term relationships with customers. We provide worldwide services in clinical research and pharmacovigilance. We work to current international and national regulatory standards and best practice. More »

Compliance Implementation Services (CIS)

Logo Compliance Implementation Services (CIS)
  • Quality management services
  • Human Medicines
  • North America

We are a consulting firm specializing in compliance strategies for the pharmaceutical industry, from Global Clinical Research and Development, through Manufacturing, U.S. Commercial Compliance, and Government Programs. Founded in 2004, we provide our clients with a deep understanding of industry laws and regulations, innovative and practical applications, and custom solutions to establish a "Culture of Compliance" that is both meaningful and sustainable. More »

SPRI Ukraine

  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Europe

SPRI Ukraine, LLC is a regional full-service contract research organization (CRO), experienced in performing clinical trials in Ukraine. We provide a wide range of research services for pharmaceutical and biotech companies, interested in conducting clinical trials in Ukraine and Russia. We are the integrated team of high professionals with expertise in managing and execution of clinical trials, offering cost-effective and time-sensitive solutions for conducting clinical studies. More »

Testo Industrial Services GmbH

Logo Testo Industrial Services GmbH
  • Quality management services
  • Biopharmaceuticals
  • Europe

Being a certified and accredited service provider in the quality assurance we are acting for well-known customers in Germany and abroad. The qualification and self-responsibility of our team are an important basis for the success. Therefore the second company's guiding principle is: 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 »

Clinstat GmbH

  • Quality management services
  • Human Medicines
  • Europe

ClinStat is an independent contract research organization (CRO) in Cologne, Germany. Since our foundation, we supported in particular pharmaceutical companies, hospital facilities, manufacturers of medicinal products as well health insurance providers and other medically-oriented institutions. We offer services for pre-clinical studies, phase I-IV clinical studies, post-marketing studies and meta-analyses in pharmaceutical research. Additionally, we are an experienced partner for epidemiological studies, studies in health services research/public health as well as studies concerning health economics. The cornerstone of success at ClinStat is our excellent team, which has a broad scientific background and profound knowledge in its field. Together, we work according to international quality standards and guidelines. Thereby, we also have the competence and capability to consider the client-specific needs. We look forward to working with you and consider your success as our mission. 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 »

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