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
- 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
- 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.
- 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
- 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
- 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.
- Pricing and Reimbursement Applications
- Full support in preparation of reimbursement and pricing approval applications with national health institutions.