Amman, June 2013 - Hikma Pharmaceuticals, the leading pharmaceutical manufacturer,announced that it has launched recently,the Regulatory Information Management System (RIMS) Corporate Program across the Hikma Group.Hikma is the first multinational company, that originated from the Arab world, to embark on the implementation of an integrated state-of-the-art RIMS in the MENA region, which conforms to the Health Authorities' regulatory requirements.
Hikma selected INFOTEHNA to provide solutions and counselling on the program's implementations which is well-known for collaborating with top multinational pharmaceutical companies.INFOTEHNA, established in 1988 in Novo Mesto, Slovenia, is the market leader in the development and delivery of integral enterprise content and process management as well as regulatory compliance solutions for life sciences industries.
Hikma plans to deploy INFOTEHNA's solution to 15 sites in 10 countries across the world and has already launched the deployment into 3Hikma companies in Jordan. RIMS will improve the overall management of all business processes, records management, and documentation to cover areas in Research and Development, Quality Assurance, Quality Control, Regulatory Submissions, and Regulatory Information Management using an advanced collaborative Document Management System (DMS). It will enable Hikma to standardize and align the industry's best practices and processes of submitting regulatory data to health authorities, through being a single and centralized on-line repository for maintaining product related documents and data in-order to plan and track the products development and registration life-cycle. Therefore, ensuring information accuracy and delivery in a timely manner and moving toward a paperless work environment in line with Hikma'scorporate responsibilitystrategy.
Elvis Pacelat, CEO of INFOTEHNA said, "In these turbulent economic times, organizations find it difficult to navigate the regulatory challenges and effectively manage the relevant content. INFOTEHNA's integral-by-design myPharmaExpertTM Suite will enable Hikma Pharmaceuticals to effectively tackle industry-specific challenges of managing global information, business processes, regulated documents and electronic records in different business areas, all in line with global regulatory requirements."
Dr. Salah Mawajdeh, Corporate Vice President of Regulatory and Medical Affairs at Hikma Pharmaceuticalscommented on the new program, "Hikma Pharmaceuticals has been always at the leading edge of innovation, market leadership and quality excellence. One of our objectives is to comply with the upcoming electronic Common Technical Document (eCTD) standard which will become mandatory worldwide, therefore, allowing us to be compliant and ahead of most, if not all, MENA regulatory authorities."
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About Hikma
Hikma Pharmaceuticals is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non branded generic and in-licensed products. Hikma's operations are conducted through three businesses: "Branded", "Injectables" and "Generics" based principally in the Middle East and North Africa (MENA) region, where it is a market leader, the United States and Europe.
For further information:
HIKMA Pharmaceuticals
Name: Hana Ramadan, Maha Hammad
Email: hramadan@hikma.com, mhammad@hikma.com
Tel: (+962) 6 5802900 Ext. 313, 356
VARCC - Arabian Communications
Name: Sara Haddadin
Email: sara.haddadin@varcc.com
Tel: (+962) 6 5547161
Fax:(+962) 6 5547162
© Press Release 2013
