SOURCE: EXTEDO

July 03, 2012 09:24 ET

Medicines Control Council of South Africa Selects EXTEDO Solution to Review eCTDs

OTTOBRUNN, GERMANY--(Marketwire - Jul 3, 2012) -  EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that the Medicines Control Council (MCC) of South Africa has selected a new solution based on EURS is Yours for its reviewing and validation project called ERES.

The EXTEDO solution will validate, import, and review electronic submission information sent by pharmaceutical companies on electronic media such as CDs or DVDs. A number of industry customers in South Africa have already started using the EXTEDO submission management solution for creating eCTD, NeeS, and paper-based submissions.

The selected solution is based on the EXTEDO EURS is Yours Solution (European Reviewing System), which has been deployed at the European Medicines Agency and many other European regulatory authorities. Regional requirements of MCC South Africa have been jointly worked out and are adopted within the new EXTEDO solution.

"Currently the drug approval process in African countries can take as long as three years," stated Tore Bergsteiner, CEO for EXTEDO. "The delays deny timely access of essential medicines to the sick. South Africa is committed to dramatically reduce registration times. It will be the first African country to start a time-effective reviewing process and accept electronic submissions instead of paper-based submissions. We are looking forward to working with the MCC to bring medicines to the South African people faster."

About EXTEDO

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.

EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.

Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare and public sector. EXTEDO is recognized as one of the worldwide leaders in each of its areas of operation.

For more information visit www.extedo.com.

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Contact Information

  • Media Contact:
    Michael Kane
    EXTEDO
    Tel: 1-978-257-2179
    Email: Email Contact