ELSAqr Europe

PRODUCT

  • Quality Management Systems;
  • Good Distribution Practices;
  • Audits.

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  • Medical Devices;
  • Medicines;
  • Cosmetics;
  • Food suplements;
  • Medicinal Cannabis;
  • Other products.

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  • Development of regulatory strategies for Europe;
  • Defining strategies for submission of new product registration processes in Europe;
  • Opinions on regulatory strategies;
  • Project management;
  • Scientific advice Roadmaps.
  • Preparation of pharmaceutical, clinical and non-clinical technical reports, in accordance with the current legislation and the best practices used.

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  • Development of a strategy for price requests and reimbursement for medicines;
  • Preparation, submission and management of price orders;
  • Annual Price Review, in accordance with the guidelines issued by the National Competent Authorities;
  • Exceptional Price Review Requests; We are a family owned and operated business;
  • Price change requests – Notified price regime;
  • Preparation, submission and management of reimbursement requests;
  • Elaboration of therapeutic advantage dossier;
  • Preparation of pharmacotherapeutic reports;
  • Preparation of clinical expert report;
  • Preparation of pharmacoeconomic studies.