Market Access

  • In/Out-Licensing Support including CTD Dossier Reviews and Verification
  • Support in Import, Export (including provision of CPPs), Promotion & Wholesale Distribution with licensed EU partners

  1. In/out-licensing Support Including CTD Dossier Reviews and Verification
  • Connection of manufacturing (active substance, bulk, final product) and distributing companies and support in their needs with experienced legal and scientific approach.
  • Identification of potential cooperation partners/sources of technology and registration dossiers.
  • Review of CTD dossiers and gap analysis
  • Support in product selection
  • Support in defining legal framework, contracts writing.
  • Broker services
  1. Business Development and Marketing Consulting Services
  • Business development: Case studies for product or line of products
  • Due diligence of manufacturing or MAH companies
  • Support in potential business partners quality audits, Quality agreements negotiation and finalization
  • Support in contacts between the different team quality, regulatory affairs, supply chain, business development, projects management, with external suppliers and health authorities in EU and WBC.
  • Market research.
  • Product portfolio analysis and consulting.
  1. Support in Import, Export (Including Provision Of CPP), Promotion & Wholesale Distribution with Licensed EU Partners
  • Full set of tailored services as per customer’s needs and in line with selected markets
  • CPP provision for pharmaceutical products licensed by national procedure in WBC, Cyprus and Bulgaria
  1. Legal Advising in Pharmaceuticals
  • Interpretation of the provisions of the EU and WBC Laws, Regulations, Rulebooks and other legal acts in terms of medicines, medical devices, food supplements and cosmetics
  • Advising in the area of the Law on General Administrative Procedure in relation to the application to Competent Authorities
  • Advising on procedural issues during proceedings before Competent Authorities
  • Advising and support in determining the legal framework (including contract writing) for potential partners, suppliers, with wide range of agreement types
  1. Pharmacoeconomic Analysis
  • Performing Pharmacoeconomic (PE) studies in order to achieve an optimal price, obtain reimbursement, support product positioning, demonstrate benefits beyond efficacy and safety.
  • Investigate the direct and/or indirect costs of a treatment and compare them to the "outcome" of the treatment.
  • Applying different types of PE studies according to the defined aims.
  • Multidisciplinary approach to study design, execution, analysis and communication of findings.
  1. Pricing and Reimbursement Applications
  • Full support in preparation of reimbursement and pricing approval applications with national health institutions.