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Regulatory Affairs White Papers

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46-50 of 50 results
Global Compliance for Medical Device Industry: Who needs Compliance to CFR, ISO13485, JPAL, D-MAH or 9100?
| By ENNOV
Medical device companies of all sizes face real challenges from emerging markets and international compliance. Many of the worlds regions are going through transformations where countries are making decisions to control their own destiny with respect to the standards and the requirements for regulatory compliance. Going, going, going gone are the days when other countries will accept the US standards and policies for managing the compliance or RAQA requirements.
Regulatory Affairs > White Papers
International Product Law Manual
| By Jardine Lloyd Thompson Limited
Jardine Lloyd Thompson Limited (JLT) was delighted to contribute to the recently published 'International Product Law Manual' by Kluwer Law International.
In addition to examining the current insurance environment for life science companies, this chapter will review the recent history of life science insurance and explain how we have got to where we are. It then identifies some of the main players, reviews the procurement process, identifies some typical policy wordings, and gives examples of how coverage can be impacted if attention to detail is not paid. The chapter then explores how claims are managed and set out practical issues to be aware of. Finally, the chapter explores recent developments that might influence the future of product liability insurance for life science companies.
*Arundel McDougall & Prashant Popat (eds), International Product Law Manual (copyright Kluwer Law International, 2010)

Regulatory Affairs > White Papers
Life Science and Chemistry Group
| By Luzzatto & Luzzatto
The role of intellectual property in the life sciences and chemical industries cannot be overestimated. Companies developing pharmaceuticals and drugs invest huge R&D resources long before they are able to prove the effectiveness of a new product and obtain regulatory approval. However the resulting products offer the potential for spectacular returns.
Regulatory Affairs > White Papers
Luzzatto & Luzzatto Company Brochure
| By Luzzatto & Luzzatto
Luzzatto & Luzzatto actively engages in all aspects of patent work, both for domestic and for foreign clients. Patent drafting, prosecution, opinions and patent and literature searches are the firm's everyday work. L&L's R&D-oriented technical staff deals with different disciplines, with particular emphasis on biotechnology, pharmaceutical and industrial chemistry, electronics, software, computer processes and mechanics, to provide a wide range of technical services and assistance.
Regulatory Affairs > White Papers
Trademark Department
| By Luzzatto & Luzzatto
Luzzatto & Luzzatto's Trademark Department comprises a leading group of lawyers who are broadly acknowledged for their IP capabilities. Our professionals possess deep knowledge and experience in developing strategy to secure, protect and enhance the IP value of the firm's clients and to suit their specific business objectives.
Regulatory Affairs > White Papers
46-50 of 50 results