REGULATORY AFFAIRS
 
 
CERTIFICATES OF SUITABILITY
TO THE MONOGRAPHS OF THE EUROPEAN PHARMACOPOEIA (CEP) from the European Directorate for the Quality of Medicines (EDQM)


CERTIFY YOUR ACTIVE PHARMACEUTICAL INGREDIENTS / BULK DRUGS (APIs)
AND EXCIPIENTS IN EUROPE AND INCREASE YOUR EXPORTS


BENEFITS :
  Certification of your APIs or Excipients by the EDQM puts your company on the world map of the
    pharmaceutical industry gives you an edge over your competitors, adds prestige, and carries
    weight in any part of the world.
  Certificates are valid in 28 European Pharmacopoeia Commission member countries and
    partially accepted in 18 observer countries.
  One-time centralized approval, 5–year validity, substitute for European Drug Master Files.
  Growth in market share, better price realization.

SERVICES OFFERED :
  In-depth Data Audit and Estimate of total expenses to achieve Certification
  cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations, and
    Documentation
  Complete guidance on EU cGMP / ICH Q7 Compliance
  Arranging Validation and Analytical Support Services
  Preparation of Application Dossiers
  Review of Application Dossiers prepared by your staff before filing
  Preparation of Quality Overall Summary (EU Expert Report)
  Filing of Applications at EDQM
  Follow-up with EDQM until Certification
  Response to Query Letters
  Major / Minor Changes / Amendments
  Renewal of Certification

OUR EXPERTISE:
  Knowledge of existing regulations and procedures, as well as future policy shifts.
  Insight into how regulatory agencies think and what data they will need to approve
    specific products.
  Extensive experience in handling many Applications and interacting with the EDQM.

ALL SERVICES PROVIDED UNDER STRICT CONFIDENTIALITY AGREEMENTS

AVOID AN ENDLESS CYCLE OF QUERIES AND REPLIES AT THE COST OF MARKET OPPORTUNITIES.
Contact the Experts…. PharmAlliance.
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