61. CDI-Life Sciences : Home CDILife Sciences is a division of CDI, a leading provider of engineering and information technology outsourcing solutions and professional staffing. We are a full-service http://cdi-ls.com/

About Us Overview History Organization About Us Overview History Organization ... CDI Corporation

62. Exalon: Electronic Submission ECTD Services Specialized on eCTD submissions. http://www.exalon.com

Home Contact Impressum eCTD Compilation ... eCTD Glossary Your partner for high quality eCTDs and regulatory submission services Our team of highly experienced professionals offers a comprehensive set of services covering all aspects of electronic drug regulatory submission business ranging from eCTD and NeeS compilation and Submission Hosting to individual processing of submission documents. In addition we provide Consulting and Trainings and support the implementation of electronic submission systems and processes in the global pharmaceutical industry. Please be invited to find out more about eCTD Compilation Submission Hosting Address Exalon GmbH Fritz-Reichle-Ring 8 78315 Radolfzell Germany Phone: +49 (0)7732.939.1650 Fax: +49 (0)7732.939.1655 e-Mail: info@exalon.com http://twitter.com/ectdexperts News EU: EDQM releases updated application forms [more] [more] FI: FIMEA releases information about experiences from e-Submission pilot phase in Finland ... info@exalon.com

63. Lifesciences: Home Network of Excellence in Life Sciences. The goal of the Network of Excellence in Life Sciences is to coordinate research and teaching activities in the field of life sciences. http://lifesciences.unibas.ch/

UNIVERSITÄT BASEL SEARCH SITEMAP CONTACT ... RESEARCH GROUPS Lifesciences Network of Excellence in Life Sciences The goal of the Network of Excellence in Life Sciences is to coordinate research and teaching activities in the field of life sciences. The network consists of managers of the following institutions: Biozentrum / University of Basel Department of Biomedicine / University of Basel Department of Biosystems Science and Engineering / ETH Zürich Friedrich Miescher Institute (FMI) School of Life Sciences / Fachhochschule Nordwestschweiz (FHNW) Swiss Nano Science Institut (SNI) Swiss Tropical Institute (STI) News and Events University of Basel: News University of Basel: Events Research Strategy Life Sciences Research Strategy Quicklinks University of Basel Friedrich Miescher Institute Swiss Tropical Institute NCCR Nanoscale Science ... BioValley What are Life Sciences? Life Sciences at the University of Basel encompass a variety of research areas that investigate all different facettes of life. They comprise the biological natural sciences, systems biology, medicine including biomedical research, research on mental health and specific areas of nanosciences, food sciences as well as some forms of engineering. An important backbone of the life sciences is constituted by computational sciences and applied mathematics. © Universität Basel Impressum

64. Veirup Consult - Regulatory Affairs Danish regulatory affairs consultancy http://www.veirupconsult.dk

VeirupConsult Regulatory Affairs English Dansk Home Service Kontakt Virksomheden Links Velkommen... Tlf.: + 45 2567 1371, CVR Nr. 30984846, e-mail: jeanett@veirupconsult.dk

65. K&L Gates : Practices & Industries : Life Sciences K L Gates’ life sciences group serving pharmaceutical, biotech, medical device, and health care clients. http://www.klgates.com/practices/ServiceDetail.aspx?service=32

66. FDA, ISO, EU And CE Regulatory Affairs Consultants: FDA Advisors, RA Professiona Regulatory affairs consultants for ISO, GMP, and FDA compliance http://abrimed.com

FDA/ISO Regulatory Affairs Consultants Phone: 949-481-5713 Email: info@abrimed.com Home Contact Services Industries ... Sitemap AREAS OF EXPERTISE FDA 510k Risk Management International State Regulations ... Business Start-ups HOME Abrimed provides FDA consulting services for the healthcare industry. Our team of experts includes regulatory affairs professionals, product design/engineering firms and other regulatory professionals. We focus on medical product development and manufacturing, from concept through testing, clinical trials, FDA/ISO regulatory compliance and ongoing manufacturing. Contact Abrimed Regulatory Consultants for.... Authorized Representatives, US Agents and Official Correspondents with the FDA ISO and FDA regulatory affairs professionals ISO 13485 and ISO 9001 registration and certification consultants Medical device development and manufacturing engineers EU CE Mark Medical Device Directive (MDD, IVDD and AIMDD) consultants FDA GMP regulations, QSR and product validation specialists FDA and ISO audit advisors Quality systems and quality assurance (QA/QC) consulting experts FDA 510k notification/submissions specialists Medical product lab testing, IEC and clinical trials consultancy

67. Kennedy Writing Service - Medical Writing & Proof-reading Medical writing and proofreading company. http://www.kennedywritingservice.com

Clare Kennedy, manager Kennedy Writing Service Sint-Dorotheastraat 12, 9040 Sint-Amandsberg, Belgium - +32 (0)472897289 KENNEDY WRITING SERVICE (KWS) is a Medical Writing and Proofreading company specialised in providing professional, efficient and trustworthy services. In the dynamic and demanding world of pharmaceuticals it is vital and of utmost importance that medical texts are written in accordance with the latest Directives. They should be written in a clear, concise and succinct manner. KENNEDY WRITING SERVICE employs experienced, reliable Native English Personnel to guarantee high standards , optimal service and above all client satisfaction. KENNEDY WRITING SERVICE is dedicated to providing its clients with perfectly written, high quality, comprehensive and convincing texts. KENNEDY WRITING SERVICE ensures that it is, at all times, informed of current developments, including the latest guidelines and regulatory requirements. AC_FL_RunContent( 'codebase','http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=9,0,28,0','width','850','height','625','bgcolor','#CCCCCC','src','ck/y/u5','quality','high','pluginspage','http://www.adobe.com/shockwave/download/download.cgi?P1_Prod_Version=ShockwaveFlash','movie','ck/y/u5' ); //end AC code Clare Kennedy, manager

68. Life Sciences Series Home The Series (In Development) LifeSciences is a TV series, of onehour magazine programs focusing on the body, mind, spirit connection and the growing human potential movement. http://www.lifesciences.tv/

The Series (In Development) LifeSciences is a TV series, of one-hour magazine programs focusing on the body, mind, spirit connection and the growing human potential movement. contact@LifeSciences.tv There is little doubt of the burgeoning interest in yoga, meditation and wellness practices in the U.S. over the past three decades.* The emerging effect of these philosophies on personal development and our potential to nurture peace, love and understanding is just now starting to unfold. Best-selling authors and opinion leaders in health, science, and spirituality will share their converging insights on pathways to higher consciousness and more enlightened social responsibility in an increasingly interdependent world. (*Please click on the video trailer above.) *More than 14 million Americans now practice yoga, spending over 5 billion dollars on yoga classes and products. 2008 Harris Survey.

69. Abnovo - EU Medical Device Authorized Representative Specialize in regulatory consulting and authorized representation in the European Union. http://www.abnovo.eu

70. NDA - Reaching Patients Fast | Welcome To NDA NDA is a European regulatory affairs and patient safety consultancy. http://www.ndareg.com

Home About NDA NDA Services NDA Advisory Board ... Contact NDA Welcome to NDA - Europe’s leading regulatory affairs consultancy NDA provides clients with a unique insight into EU regulatory thinking and the best possible expert guidance and support to optimise the time to the European market. NDA’s mission is to ensure that patients get access to good medicines without unnecessary delay. NDA has successfully delivered on this promise for over ten years. In 2009 NDA was involved in more than 30% of all positive opinions under the EU Centralised Procedure! The experience and knowledge of NDA's regulatory consultants are unmatched in Europe. EMA Calendar Online Brochure Client Feedback The latest NDA news Bio-Europe 2010 More of this story > Future assessment of the Immunogenicity of therapeutic proteins The assessment of immunogenicity-related risks and the implementation of a suitable risk management strategy that evolves during the life cycle of a biopharmaceutical product, is now recognised as an essential regulatory practice. More of this story > Job Opportunities Legal Notice Site Map ... Withdrawal Management / Shutdown The NDA Group is an independent consulting organization delivering services within outcome oriented drug development focused on the strategic and operational aspects of regulatory affairs . NDA provides assistance to both the Pharmaceutical Industry as well as Regulatory Agencies . The ultimate objective of NDA is to help to develop better medicines that reach the patient without unnecessary delay. NDA achieves this objective by critically reviewing client project development plans with the aim that they are optimized to meet the needs of regulatory authorities and then to help to implement those strategies. NDA strives to bridge the communication gap between "the regulators" and "the regulated" to the benefit of patients.

71. Graduate Program In Life Sciences, University Of Maryland Baltimore Welcome. The Graduate Program in Life Sciences (GPILS) offers cutting edge research training in basic, biomedical, clinical and population sciences. http://lifesciences.umaryland.edu/

72. Welcome To Thermal Compliance Ltd Thermal mapping and autoclave validation http://www.thermalcompliance.co.uk

Welcome to Thermal Compliance Ltd Thermal Compliance Ltd is a specialist independent company delivering quality thermal mapping and validation solutions to the healthcare, pharmaceutical and biotechnology industries internationally. We offer a range of validation services for process, manufacturing, hospital and laboratory facilities, including: Thermal and biological validation of sterilisation processes. Sterilisation process audits and troubleshooting. EN 285:2006 Testing Thermal Mapping of hospital, laboratory and process equipment from -80°C to 400°C. Including Freezers, Fridges, Incubators, Cold Storage etc. We specialise in Autoclave Validation , ensuring that your sterilisation process is qualified to cGMP and regulatory expectations. For more information on how we can help you and your compliance needs please browse this website, call us on 00 44 161 686 2859 or email us at: enquiries@thermalcompliance.co.uk Brochure Download The latest Thermal Compliance brochure is now available for download by clicking on the link below. If you would like a copy mailed please e-mail us at enquiries@thermalcompliance.co.uk

73. Home | U.S. Army Research Laboratory ARO Life Sciences Life Sciences. U.S Army Research Office ATTN RDRLROP-L P.O. Box 12211 Research Triangle Park, NC 27709-2211 http://www.arl.army.mil/www/default.cfm?Action=29&Page=181

74. PRS Clinical Provider of clinical trial services http://www.prs-clinical.com

Leadership Change at PRS Clinical Russia We are happy to announce the new General Director at PRS Clinical Russia PRS Clinical Ltd Opens an Office in Belgium As part of our continuing expansion of services, PRS Clinical opened an office in Zaventem, Belgium. PRS Clinical Expansion in the USA PRS Clinical Ltd is proud to announce its expansion into the United States. PRS Clinical, Ltd. is a full service Clinical Research Organization (CRO), offering clinical trial support in Phase I-IV studies, with operations in strategic countries on all continents. These countries are characterized by significant numbers of potential study subjects, often unmet medical needs, certain disease types that may not be as prevalent elsewhere, and highly qualified investigators. Data developed in local research centers have been shown to be of high quality and acceptable to the most demanding regulatory agencies worldwide. Our main specialization is strong local presence in each of the markets, thorough understanding of local medical practices, customs, languages, as well as local research and regulatory requirements. We work through a network of pre-qualified, experienced investigators, which helps ensure strict GCP compliance, competent research activities, and high quality of data. Unlike some other CROs that often start looking for potential local monitoring support only when bidding on a multinational project, our existing global organization offers up-to-date regulatory consulting about local requirements, easily performs thorough feasibility studies, and allows rapid study start-up with subsequent good enrollment of patients.

75. Life Sciences & Pharmaceutical Consulting - Charles River Associates Take a closer look. A global pharmaceutical company abandoned a product launch following unfavorable clinical trial results. When their stock price fell, they were sued for http://www.crai.com/ConsultingExpertise/content.aspx?tID=900

76. ICH GCP (Good Clinical Practice) Training Course Online good clinical practice training. http://www.onlinegcp.com

77. Life Sciences Legal Blog : Fox Rothschild: Corporate, Food And Drug Administrati The U. S. Food and Drug Administration is announcing a final rule that will improve the quality of safety reports and better protect people participating in clinical trials for http://lifesciences.foxrothschild.com/

Life Sciences Legal Blog : Fox Rothschild: Corporate, Food and Drug Administration (FDA), and Business Entity Legal Issues Published By Fox Rothschild LLP Legal developments affecting life sciences companies ... Archives Posted on October 28, 2010 by Lindette Hassan USPTO and EPO Partner to Create Joint Classification System The United States Patent and Trademark Office ( USPTO ) and the European Patent Office ( EPO ) have agreed to work together to form a joint patent classification system. One of the goals of the partnership is to align the U.S. and the EPO classification systems with the International Patent Classification (IPC) system used by the World Intellectual Property Organization ( WIPO ), a specialized agency of the United Nations. The jointly developed classification system will be more detailed and designed to improve patent searching. As a result, the two offices will move closer to eliminating the unnecessary duplication of work between the two offices, thus promoting more efficient examinations, while also enhancing patent examination quality. Currently, the USPTO classification system

78. Medical Device Consultants Located in the Toronto, Ontario (Canada) region. http://www.medicaldeviceconsultants.ca

79. NAI Global Life Sciences Group > Home The NAI Global Life Sciences Group provides a broad array of specialized services, including corporate services, tenant representation, acquisition/disposition and facilities http://nailifesciences.com/

var isDST = true; Home NAI Global Contact Us Our Services ... Our Clients The NAI Global Life Sciences Group provides a broad array of specialized services, including corporate services, tenant representation, acquisition/disposition and facilities management to key players, both large and small, throughout the life sciences industry. NAI Global offers the most comprehensive market coverage with offices in all of the primary markets as well as most secondary and emerging markets around the globe. Our experienced local professionals have deep roots in their local communities and are on familiar terms with the major property owners, tenants and government agencies and both public and private economic development entities. Our life sciences professionals are strategically spread across the key life science clusters and emerging cluster markets. Whether your needs, are local, national or around the world, we invite you to build your business on the power for our network. Robin Anders Ted Parcel Anthony Scuilla Our client list includes: Abbott Laboratories Aceto Chemical Corp.

80. Winckels Medical Devices Expertise - CE Mark Medical Devices Medical device regulatory affairs http://www.wmdegroup.com

HOME WMDE (Winckels Medical Devices Expertise) was founded in 1999 and has provided support to many leading medical device companies to comply with the Quality and Regulatory requirements for their medical devices to the European legislation. WMDE has also provided these companies with sterilisation solutions. Winckels Medical Devices Expertise: CE-marking/ Regulatory Support FDA approval USA Authorized European Representative Sales and Marketing Advice Quality Assurance PAL Japan ABOUT US WMDE can rely on a broad experience within leading medical devices (i.e. Medtronic) and pharmaceutical companies (i.e. GlaxoSmithKline), chairmanships with CEN (Committee for European Standardisation) and ISO and ongoing education in the fields of European legislation... read more Download our brochure in Japanese Download our brochure in Chinese CONTACT Click here for contact information

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