Our services

We believe in curiosity and developing insights by challenging each other.

Our Regulatory Affairs services include healthcare policy and all aspects related to obtaining and maintaining registration of therapeutic solutions. Market Access services include strategic positioning, pricing, and reimbursement, HEOR and managed entry agreements. Services for Medical Affairs include creation and implementation of materials and projects supporting scientific engagement, data generation (RWE) and scientific/market/stakeholder insights. Flexible staffing allows us to provide temporary FTEs to companies on a time or project basis.

WHY AXTALIS?

• Multidisciplinary approach: We don't look at a specific challenge from one angle, but we take into account a broader set of priorities, and have various functions weigh in on the issues at hand.

• Experience: As the AxTalis team has worked in multiple therapeutic areas, we easily understand and navigate in different therapeutic landscapes. We pride ourselves on the ability to quickly come to grasp with new areas and technologies.

• Network: Our network spans the broad spectrum of stakeholders and we speak their language.

• Expertise: In building experience across a wide range of therapeutic areas, we have developed in-depth knowledge and expertise in Oncology, Haematology, Neurology, Immunology, Pain Management, Cardiology, Diabetes, Nephrology, Ophthalmology, Gastro-enterology, Respiratory, and many others.

Regulatory affairs

AxTalis Regulatory Affairs provides strategic and technical advice at the highest level throughout the lifecycle of a healthcare solution and helps set the stage for current and future commercial success. Indeed, we see RA not only as a necessity, but as a key partner in the continuous re-evaluation of the scientific and commercial offering, such as indications, SKUs, safety aspects, RMP/RMA etc. The close collaboration with our clients and with the AxTalis Access and Medical Teams allows a targeted intervention to ensure the optimal life cycle management with its obligations and opportunities. 

• Marketing Authorizations Applications (Centralized, Mutual Recognition, Decentralized or National Procedures)

• Product regulatory and legal status

• Submission and life cycle management (mod. 1-3)

• CMC expertise

• SmPCs, package insert/instruction for use and labelling (multi-language)

• European regulatory strategy and representation

• Review and interpretation of regulatory and scientific regulations

• Expert report preparation

• Non-routine Risk Minimization Activities

• Unmet Medical Need & Compassionate Use procedures

• Nutrients & biocide notification, submission, and maintenance

• MDD 2017/745 and IVD 2017/246, including harmonized standards

• GDP consultancy

• Pharmacovigilance support (local contact person and EU QPPV responsibility)

• Audit & Inspection readiness (PV, GDP)

• QP, RP & RIP

• Falsified Medicines Directive requirements and follow-up

Market Access

AxTalis understands that navigating healthcare systems is complex and not always straightforward as different stakeholders have different needs. By focusing on the key pillars of clinical research, health economics, market research and real-world outcomes research, AxTalis provides stakeholders with the knowledge and insight required to facilitate decision-making. As market access specialists, we work directly with patients, medical specialists, economists and the authorities to find common ground with one goal in mind – access to new technology for patients in need.

• Design of Patient and treatment flow

• Clinical data analysis

• SWOT analysis

• Data gap mitigation plan

• Dossier writing

• Value communication

• Epidemiological research

• Early Access programs

• Development of pricing file

• Pricing research

• Pricing scenario analysis

• Indication based pricing

• HEOR Budget Impact Analysis

• Health Economic Analysis

• Sensitivity analysis

• Strategic RWE (outcome research)

• Innovative Managed Entry Agreements

• Scenario testing

• Evidence generating reimbursement

• Early dialogue with buyers

• KOLs and HCPs

• Scenario testing

• Value communication

• Market Access Ad boards

• Delphi panels

• Training

• Parliamentary discussion groups

• Patient preference exercises

Medical Affairs

Axtalis considers Medical Affairs to be a key driver with a critical strategic impact in a healthcare organisation. Medical Affairs helps to define a prioritised strategy that tackles the most important challenges and grasps the most interesting opportunities. Reaching out to the external medical community and engaging with KOL’s, makes Medical Affairs well placed to gather insights and communicate the evidence on how the medical innovation fits the landscape and how it brings value to providers, patients, and payers.

• Early Access programs

• Real World Evidence & phase IV

• Patient Oriented Programs

• HCP projects such as speaker kits

• Advisory boards

• Insights gathering

• Medico/marketing projects

• Medinfo service

• Pharmacovigilance

• RIP activity

• Creation of materials

• Content for visual aids, brochures

• Strategic/tactical plans

• Scientific training

• SOP creation

• Project evaluation and planning

• Portfolio management

• Investor relations

• Review for investment funds