European Authorized Representative
When is an EU Authorized Representative (EC REP) required?
The European Union requires any foreign manufacturer who intends to sell their devices in any of the Member States to designate a sole authorized representative (EC REP) with a physical address within one of the Member States. LaNova Consulting will represent your company to the national authorities and Notiffied Bodies.
LaNova Consulting as an authorized representative under the MDD/MDR and IVDD/IVDR. With the introduction of the MDR and IVDR, the authorized representative is considered an economic operator and shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
Due to the increased liability under the MDR/IVDR, we have updated our processes and systems to meet the requirements underlying article 11.
Like to market your device?
After completing the mandate, we will review your technical documentation and provide support where necessary.
Clinical Research Organisation
LaNova Medical has been ensuring clients in the biotechnology and pharmaceutical industries achieve their clinical research goals for more than 20 years. As experts in the planning and delivery of clinical research, we understand the importance of time, cost and quality, and are able to guarantee these metrics are met. LaNova Medical offers a comprehensive portfolio of services which can be tailored to meet the individual needs of each client.
Medical Device and In-vitro Diagnostics
The LaNova Medical Device and IVD team knows and understands medical device and diagnostics regulations; most of the staff have been through the regulatory process for clinical trial and product approval in the USA and EU many times. Therefore our operational team understands the regulatory implications of its actions and decisions, so your clinical study or regulatory submission is in safe, expert hands. We are also able to offer our clients the benefit of a large collective experience when formulating and implementing regulatory strategies and study designs, and LaNova Medical flat management structure means that this experience is not lost within a vast organisation.
The members of our Drug Safety Team have biological, medical or pharmaceutical background and at least more than 20 years experience in Drug Safety Data Entry, Literature Surveillance and MedDRA Coding. We can offer a wide range of services in the field of Drug Safety, both as full and part service solutions. Our team has the critical knowledge of the regulatory requirements and the medical competence required and offers pharmacovigilance services during clinical development as well as after marketing authorisation.
- Review of Global Medical Literature
- AE / SAE / ADR collection and evaluation
- Data Entry into Drug Safety Databases
- Analysis and case reporting
- MedDRA Coding
- Assessment through medical trained personnel
- Quality checks
- DSUR, PSUR and RMP writing
Our services are in full compliance with European Drug Safety regulatroy requirements. Wheterr you are applying for a new Marketing Authorisation, need to maintain one, or are making changes to your PV due to Breaxit, we are here to help build and manage your PV system, including the role of European Qualified Person for Pharmacovigilance.
Use our solution, and we will make sure you pass any regulatory inspection or audit coming your way. We are also conducting PV audits and supporting inspections with a experience with more than 15 years.
Market Access Consultancy
Preparing your best market access strategy
When thinking about getting new pharmaceuticals to the market, many companies focus efforts on getting products through approval, and so tailor their market access strategy to meeting the regulators’ needs. However, for a successful market access, any company needs to have a strategy to meet the needs of the payers as well as the regulators.
A winning market access strategy is needed for both clinical and commercial success, as the product must provide benefits to patients, and it must also provide a return on investment for the companies developing the drugs.
To achieve this, companies need to embrace market access strategy as an aim from the beginning, which requires understanding the needs of patients, focusing on payer perspectives, and providing pragmatic solutions that work in the real world.
Audits & Inspections
We ease the burden of your workload during planning and conduct of your GxP/GMP audit, create detailed and product-specific audit reports based on current guidelines and your individual specifications in a timely manner and, last but not least, monitor the initiation of any potentially required corrective actions. In addition, we offer support during preparation for a re-audit.
GxP is an umbrella term not only for Good Clinical Practice, but also for various other surveillance domains. Qualified persons hit resource bottlenecks due to increasing GxP audit obligations. Staff-intensive, time-consuming and costly audits, which are usually associated with enormous travel requirements, can hardly be efficiently managed by the in-house staff. blue inspection body can help – as your external, accredited, independent 3rd party auditor!
Based upon our exceptional experience, knowledge and understanding we exceed customer expectations. We handle audits of finished does drugs and all other GxP audits with the same level of professionality as well as detailed – regardless if the audit requires an accredited or non-accredited report. Our GxP service range.
Clinical research professionals must be fully equipped with all the skills, tools, knowledge and proficiency in best practices in project management techniques, clinical research and more specifically Good Clinical Practices.
Based upon the acute necessity of GCP knowledge and skills in the research enterprise, upon recommendation of the CRS Executive Committee, GCP Training and Certification has been made available to all Professional members of the Clinical Research Society. The GCP Training & Certification program is also available to CRS Non-members.
Training is delivered through multimedia presentations, case scenarios and other useful resources. Our endeavor is to make the learning effective albeit easy and convenient.
Providing Intermin Management
LaNova Medical is providing Interim management as a temporary provision of management resources and skills for Pharma, BioTech and Medical Device Companies in the following departments:
- Medical Affairs Department
- Clinical Operations Department
- Market Access Department
- Pharmacovigilance Department
- Qualitiy Assurance
We, within LaNova Medical defined Interim management as a short-term assignment of a proven heavyweight interim executive manager to manage a period of transition, crisis or change within an organization. In this situation, a permanent role may be unnecessary or impossible to find on short notice.
Contact us today to find out how LaNova Medical can help you.