MARKET ACCESS
REGULATORY AFFAIRS
PRICING & REIMBURSEMENT MARKET ACCESS STRATEGIES shaped according to the local healthcare environment (pricing & reimbursement, strategies on patient fast access) Strategy and reimbursement consulting Pricing strategies for the market entry of new products including preparation, submission, correspondence and follow-up of the pricing dossier and application Activities aimed at the inclusion of new products in the Reimbursement Lists: reimbursement strategy, preparation, submission, correspondence and follow-up of reimbursement application and dossier Design of mechanisms and strategies to increase market access for products already reimbursed Access programs specially tailored to your product REGULATORY SOLUTIONS for human and veterinary drugs, vaccines, food supplements, and medical devices, addressing all types of challenges posed by EU legislation: Consultancy on the Romanian regulatory environment related to medicines, medical devices, food supplements, etc. Customer representation towards Romanian regulatory bodies Preparation of documents in compliance with the requirements of local regulations for registration including creation of some parts of the dossier, application form and translations for the new product registration / renewal procedure until issuance of Marketing Authorization Submission of the application to competent authority, correspondence and
follow-up with the authorities during procedure All post-approval regulatory activities: switch to OTC, transfer of Marketing Authorization, approval of packaging according to local and EU regulations, submission of variations and line extensions, renewals, PSUR's submission, submission of promotional materials and all other related regulatory activities to ensure compliance with Romanian legislation Reports of analysis and impact of regulatory change Regulatory Intelligence activities Pharmacovigilance Internal audit (alignment to authority requirements, norms)
CLINICAL RESEARCH Link Resource has the capabilities to provide consultancy for the management of clinical trials: Investigators' database Verification of mandatory trial documentation Creation and/or translation of study-related documents Medical advisory on CRF design Negotiation of contracts with investigators/institutions Obtaining regulatory & ethical committee approval Logistics of study related materials and drugs Site initiation, monitoring and closing Patient recruitment know-how Investigator training on protocol, laboratory techniques, randomization system, electronic data management SAE and medical support 24/7 of investigative sites Independent consultancy for audit Site preparation for inspections
STRATEGIC, TACTICAL MARKETING &
MARKET INTELLIGENCE Link Resource can build or enhance your market position by offering support in: Qualitative and quantitative research, particularly market segmentation that gives you growth-oriented insights Product analyses based on potential of specific markets and competitive analyses Strategic portfolio evaluation and competitive positioning Profit-focused modeling to assess the financial impact of different marketing decisions Marketing strategy development, planning, and implementation to provide you with relevant action steps for improved business performance Launch strategies and launch plans for new products Life-cycle management stage-customized strategies Promotional strategies and tactical marketing and sales plans Sales promotion activities: organization of seminars, symposia and conferences in pharma and healthcare Licensing in and out Selected market research Design of business development strategies
COMMERCIALIZATION PLATFORM
DEVELOPMENT SUPPORT Link Resource team members have a vast commercialization experience, validated by the successful launch and commercialization of over
50 pharmaceutical products over the past two decades. Link Resource can support you in building or improving your high-productivity strategies in the Romanian and EU markets through: Customized, interactive approach to identifying logistic models and commercialization planning Solid portfolio of well developed strategies, and aligned tactics as well as the proven ability of coordinated execution Strong commercialization strategy: defining business opportunity, positioning, setting goals, priorities and critical success factors Effective commercialization planning: construction of cross-functional tactical plan, setting realistic timelines and budgets, defining team members roles and responsibilities Assistance and follow-up for seamless execution Setting monitoring and reporting patterns Solutions in Supply Chain Management and technical services, logistic programs New operational models in distribution - DTM (Direct to market) conversion Regulatory and Quality Assurance consulting related to distribution & sales
OPERATIONS MANAGEMENT Link Resource can support the optimization of processes and workflows through: Solutions for supply chain management optimization: DTM (direct to market) Support for the development of management models at strategic, tactical and operational levels Optimization of interfaces between Operations Management and other business compartments: Marketing, Management, Finance, Service Operations Solutions for streamlining and optimizing operations performance: Reducing the development and manufacturing time for new goods and services Achieving and sustaining high quality while controlling cost Integrating new technologies and control systems into existing processes Working effectively with suppliers at being user-friendly for customers Working effectively with new partners formed by strategic alliances Solutions for business development & interim management
ertrete