• eCTD
• Abridged Applications
• National Procedures
• Mutual Recognition
• Decentralised Procedure
• Variations
• Renewals
• Paediatric Investigation Plans (PIPs) and
  Paediatric Use Marketing Authorisations(PUMAs)
• Certificates of Suitability
• Biostudy Management
• Regulatory Strategy
• Pharmacovigilance
• Compliance
• Herbal Medicinal Products
• Training
• Veterinary Medicinal Products
• Project Management

Certificates of Suitability (CEP)

• The European Directorate for the Quality of Medicines (EQDM ) is the body responsible for granting CEPs to active pharmaceutical ingredients which are monographed in the European Pharmacopoeia.

• An active pharmaceutical ingredient manufacturer may apply to the EQDM for a CEP for any chemical entity which has a monograph in the European Pharmacopoeia.

• The EQDM also issues CEPs for any product with a possible associated TSE risk.

• Ivowen Limited can provide advice on how to prepare your submission for a Certificate of Suitability for your drug substance.

• Ivowen Limited can review the data that you are planning to submit to obtain a Certificate of Suitability.

• Ivowen Limited can prepare your submission for a Certificate of Suitability.

• Ivowen Limited has full eCTD capability