Intrasphere Technologies, a leading consulting firm that provides business-focused services and solutions to life sciences organizations, announced recently that it will be showcasing its PharmaCM Structured Content Management solution, powered by Microsoft Office SharePoint Server (MOSS) 2007, at the DIA 1st Indian Annual Regulatory Conference; Building Bridges Between the Regulators and the Pharmaceutical Industry, in Mumbai, India, April 27-29, 2008, at InterContinental The Grand Mumbai.
At this event Intrasphere will be demonstrating its PharmaCM Structured Content Management solution which helps companies address the challenges of regulated content management by enabling users to overcome ineffective content authoring, management and distribution processes. Companies are able to streamline content creation and collaboration, convert content into actionable information, improve the ability to meet and answer regulatory needs, as well as transform content into appropriate regulated standards. Using the OpenXML standard along with MOSS-based artifacts and assemblies, PharmaCM provides an innovative, yet easy to use solution. PharmaCM is composed of the following three comprehensive modules:
- Clinical Trial Registration: Gather accurate clinical trials information and easily manage the complex process of authoring, reviewing, approving and uploading study content to ClinicalTrials.gov
- Submissions Management and Authoring: Easily plan, track and author regulatory content ranging from IND to NDA as well as Annual Reporting content. Manage global submission projects and gain insight into planning content contributors, reviewers and approvers workload.
- Product Labeling: Provides an easy-to-use label authoring environment to create heavily formatted printed labels (USPI, PLR, PPI) and leverages the power of Microsoft Word and the OpenXML standard to convert the printed labels into the electronic label format (SPL).
The following key objectives of the conference will help bridge the gap between regulators and industry over the next decade:
- Discuss the Evolving Indian and Global Regulatory Environment
- Recognize the Requirements of Indian Regulations
- Discuss Future Drug Development Science
- Identify Current Challenges around Quality, Safety and Efficacy
- Evaluate International Trends and Global Harmonization Opportunities.
About Intrasphere Technologies
Intrasphere Technologies, Inc. (intrasphere.com) is a consulting firm focused on the Life Sciences industry. We provide comprehensive, business-focused services that help companies achieve meaningful results. Our professionals leverage strategic acumen, deep industry knowledge and proven project execution abilities to deliver superior service that builds true business value.
Our strategy, business process and technology services are developed to specifically address areas that are most important to our clients including; Drug Safety, Content Management and Portals, Structured Content Management (PharmaCM), Corporate IT, Business Intelligence and Regulatory Compliance, to name a few. We understand the unique nature of the Life Sciences working environment and clients’ need to reduce costs, drive business processes and speed-to-market, while satisfying regulatory mandates.
Some of the world’s leading global companies including Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE: JNJ), Novartis (NYSE: NVS), Eli Lilly (NYSE: LLY) and Vertex Pharmaceuticals (Nasdaq: VRTX), among others, look to Intrasphere as their trusted solutions partner.
Founded in 1996, Intrasphere is headquartered in New York City with operations in Europe and Asia. Intrasphere has been recognized nationally for performance by industry leading organizations such as, Deloitte & Touche, Crain’s New York Business and Inc. Magazine.