Services

Business strategy

Develop comprehensive transformation / culture change strategies to address challenges in the rapidly evolving Life Sciences landscape.

Identify and prioritize impactful activities to catalyse business growth and outperform sector competitors.

Reimbursement - PICO models

Navigate the complexities of consolidated PICOs across EU Member States for joint clinical assessments.

Develop strategies to manage potentially unmanageable numbers of PICOs due to varying definition of standard of care and patient sub-populations.

Market access

Create holistic, cross-functional real-world evidence strategies to effectively communicate value to stakeholders.

Develop pricing, reimbursement and market access strategies that balance the needs of critical stakeholders.

Network building

Facilitate the consolidation of independent clinical trial sites into larger, integrated networks.

Develop strategies for building stronger, more transparent relationships between stakeholders at national, pan-Baltic, CEE or pan-European level..

Patient engagement

Develop and implement company-wide or disease-specific patient-centric engagement strategies tailored to national, pan-Baltic, CEE, pan-European culture.

Create effective patient education and support toolkits, action plans with a focus on health literacy, EDI practices, capacity building.

Culture change

Implement strategies to reverse lagging patient engagement practices within the company.

Conduct trainings to the workforce on emerging trends in patient engagement, patient advocacy, health policy, legal and compliance matters.

Global trend insights

Analyse emerging markets and shifting population trends to identify new opportunities for Life Science companies.

Provide insights on regulatory changes and their impact on drug development and market access strategies.

Real-world evidence generation

Design and implement real-world evidence strategies to support regulatory approval, market access and post-marketing authorisation needs.

Develop data strategies to identify priority use cases, obtain datasets, and leverage partnerships for evidence generation.

Guidance on financial regulatory environment

Tailored value propositions for market entry - crafting bespoke value propositions for expansion projects, evaluating all site selection criteria such as infrastructure, technology, cost advantage, talent pool and other.

Regulatory framework guidance - advising on legal and fiscal environments to align with global and local standards.

Sector-specific guidance

GMP, CMC, ATMP - providing insights into Good Manufacturing Practices (GMP) local set-up, and Advanced Therapy Medicinal Products (ATMP) trends, finding key experts on specific technology or processes.

Guidance on the Clinical Trials in the EU - connecting with local and foreign experts to deliver desirable client outcomes.

Multi-stakeholder leadership

Facilitate alignment and communication between diverse stakeholders at national, pan-Baltic, CEE and pan-European level.

Create and lead multi-stakeholder initiatives, consortiums, platforms.

Financial growth

Investment attraction across different stages in pharmaceuticals, biotech fields.

Mergers and acquisitions - finding the right partner, negotiating and finalizing agreements.

Global representation

Networking - on behalf of the client establishing connecting with key opinion leaders, industry players, and other leaders to drive the company’s growth.

International representation - representing clients at international conferences, panels, and thought leadership forums, connecting with specific media to increase visibility and reach sales targets.

Market research

Conducting in-depth analysis to identify and understand target groups, which include users and payers, to tailor health tech solutions effectively.

Providing comprehensive market access recommendations that are both focused and feasible, ensuring the successful entry and sustainability of health tech products in the market.

Biotech regulations (Eudralex)

Guidance on EMA legal framework for starting materials of pharmaceuticals (including biologicals).

Assistance for preparation of GMP compliance documentation.

Piloting projects

Building up and management of biomedical research projects or other proof of concept (POC) projects to collect determined Real World Data (RWD) and Real World Evidence (RWE).

Implementation of pilot projects to evaluate new healthcare services and service provision models in diverse settings.

Medtech regulations (MDR)

Comprehensive consultation on MDR requirements for all classes of medical devices

Consultations on post market surveillance.

Biomedical research design

Assistance on building up and implementation of a biomedical research.

Guidance on the design and implementation of biomedical research projects to ensure robust data collection and analysis.

Bioethics

Guidance on ethical considerations in biomedical research, ensuring compliance with regulatory standards and safeguarding patient rights.

Support for the secondary use of data, including consent management and ethical review processes to maintain data integrity and privacy.

HTA & Reimbursement

Building solid clinical and health economic evidence to support Health Technology Assessment (HTA) submissions and secure reimbursement for new healthcare interventions.

Providing comprehensive evidence to payers to demonstrate the value and effectiveness of healthcare services and ensure their inclusion in reimbursement schemes.

Karolina Karl

Sarunas Narbutas

Justina Januseviciene

Founding Team