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2012.01.28

The EMA released a draft guidline on biosimilar interferon beta for public consultationNEWS

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β)
26 …more
2011.12.22

[Guidance for Industry] FDA announced a guidance for industry regarding ‘Regulatory Classification of Pharmaceutical Co-Crystals (DRAFT GUIDANCE)’ (Published 12/1/2011 )NEWS

In response to the need for regulatory guidance, this draft guidance provides our current thinking o…more
2011.10.12

“[Guidance for Industry] FDA announced a guidance dor industry regarding ‘Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting’. (Published 10/11/2011 )”NEWS

Pharmaceutical manufacturers aiming to thwart drug product counterfeiting have been investigating re…more
2011.10.08

European Medicines Agency invites feedback on plans to revise existing guidelines on biosimilar medicines and influenza vaccines (Published 2011/10/3)NEWS

The European Medicines Agency (EMA) published a concept paper on its proposed revisions to the agenc…more

Business Alliances

  • Japan | eCTD | Digital Media Systems, Co. Ltd.
  • FDA | GxP Compliance | Polaris Compliance Consultants, Inc.
  • EU域内 | Pharmacovigilance and Legal Representative | Verius, Ltd.
  • EU | Clinical Supplies | Biotec Services International. Ltd.
  • EU | Contract Research Organization | Harrison Clinical Research Deutschland GmbH
  • Headquarters
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  • CoreMed America, LLC
    2111 Wilson Blvd., Suite 600, Arlington, VA 22201, U.S.A.
    (TEL) +1-703-283-7661 (Cell)
    (TEL) +1-703-351-5034
    (FAX) +1-703-351-9292

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