International Market Access and Regulatory Affairs

our support for international projects

Scope

International Regulatory Affairs through our partner in EU

Regulatory support and management from early

development throughout the whole life-cycle of a

medicinal product

Global Market  Access

Risk Management and Product Safety

Local associates in:

 Albania

 Bulgaria

 Bosnia & Herzegovina

 Czech R.

 Hungary

 Kazakhstan

 Kosovo

 Macedonia.

 Serbia

 Slovenia

 Slovak R.

 Romania

 Russia

 Turkey

 Ukraine

 Uzbekistan

 Regional market size about 500 million citizens.

Extended by our EU partner network

                          Network centered on regulatory affairs

• Network plus combined partners currently include
• coverage – approx. 94 countries
• 15 members with > 140 staff members
• 23 RA-Partners with > 100 staff members
• > 150 associates (experts)
• Network growth driven by client demand
• Use of partners done when improving process without

increasing overall costs

Marketing authorisation Applications

• Dossier Preparation:
• Module 2.3 and 3, Drug Master Files
• Preclinical and clinical summaries and overviews
• Pre-submission meetings
• Submission of marketing authorisation applications
• Follow-up including answering of authorities’ concerns
• Translation services
• Variations, Renewals
• Marketing Authorisation holdership

• Centralised Procedure (CP)
• Mutual Recognition Procedure (MRP)
• Decentralised Procedure (DCP)
• National procedures (Balkan, Russia, Ukraine, Belarus,
EU, CH, USA, Canada, Latin America, East Asia, others)
• SME status application at EMA
• Paediatric Investigational Plan (PIP)
• Orphan Drug Designation (ODD)
• Rx to OTC switch

Market Access

• Regulatory landscape
• Pricing and reimbursement, including, for prescription
drugs and medical devices, the requirements of the
payers and key decision makers
• Distribution channels and trade margin structure
• Distributor/partner selection
• Maximise value from the asset
• Regulatory approval of promotional materials

Regulatory strategy

• Evaluation of technical data (chemistry/manufacturing,
preclinical, clinical), for determination of the appropriate
regulatory and legal status
• Consultation with regulatory authorities to consider their
scientific advice and protocol assistance
• Propose optimal filing and submission strategy
• Establish frequent contact with regulatory authorities
• Interpreting regulations and guidelines

Project Management

• For entire projects or individual steps
• Defining the product development concept
• Design & management of development programs (quality,
preclinical and clinical)
• Control of the various steps of the development process
• Selection, qualification and management of vendors
• Quality Assurance
• Due Diligence
• Preparation, control and monitoring of budgets

Audits

• GMP audits of drug substance and drug product
manufacturers
• GMP audits of investigational medicinal products
• Supply chain audits, warehouses and distributors
• Preclinical study audits (GLP and non-GLP)
• Clinical study audits at CROs, sites and other vendors
(GCP and GLP)
• Pharmacovigilance audits
• Qualification of vendors
• Inspection preparation audits

Pharmacovigilance

Complete PV system set up and ready:
• Description of pharmacovigilance system
• Preparation of pharmaceutical safety master files (PMSFs)
• Development safety up-date reports (DSURs)
• Periodic safety up-date reports (PSURs)
• Risk management plans
• Management of pharmacovigilance vendors
• Medical back-up for QPPV

Clinical Trial Applications - IRB/Ethics

• Preparation of Investigational Medicinal Product Dossier
(IMPD)
• Preparation of IMPD/IND
• Investigator’s brochure
• Filing of application(s) to authorities
• Filing of application(s) for IRBs/ethic committees
• Follow-up and amendments
• Notifications (end of study, submission of final study
report)

Regulatory due diligence for mergers and acquisitions

• Due diligence for all regulatory matters in mergers and
acquisitions provided by a cross-functional team,
selected to cover the specific needs of clients
• Services offered include a review and assessment of:
• Product supply, including GMP aspects and audits
• Product portfolio and pipeline (gaps, competitors, development
plans, regulatory status and compliance etc.)
• Resource (staff, equipment, expertise) in regulatory affairs