Pharma and BioTech
CRO Services
For more than 25 years, LaNova has been helping clients in the biotechnology and pharmaceutical industries achieve their clinical research goals. As experts in the planning and delivery of clinical research, we understand the importance of time, cost and quality, and are committed to meeting these key metrics.
We cover the complete Drug Development Circle, if necessary, with our well-rehearsed co-operation partners.
Pharmacovigilance
We offer a wide range of PV services and Medical Review, available as full-service and partial-service solutions.
With in-depth knowledge of regulatory requirements and strong medical expertise, our team provides high-quality pharmacovigilance services throughout clinical development and post-marketing authorisation.
Qualified Person for Pharmacovigilance (QPPV)
Whether you are applying for a new Marketing Authorisation, maintaining an existing one or adapting your pharmacovigilance (PV) system, we are here to support you. Our Expertise includes building and managing your PV system, as well as fulfilling the role of the European Qualified Person for Pharmacovigilance (QPPV) or on national country levels.
By choosing our solutions, you can be confident in passing any regulatory inspection or audit coming your way. With 25 years of experience, we also conduct PV audits and provide expert support during regulatory inspections.
Quality Management System Implementation
We provide strategic compliance consultancy at every stage, helping clients through all stage gates towards and beyond commercialization, consulting with them on anything that will impact the quality and compliance of the final product.
Our Quality Management Team also conducts internal as well as external audits, including those requested by clients.
Market Access Consultancy
A successful market access strategy starts from the very beginning. We help you build a plan that supports your clinical, commercial, and financial goals, enabling your product to succeed in the marketplace.
- Comprehensive Market Access Strategy: Tailored to meet the needs of regulators and payers, ensuring both clinical and commercial success for your products.
- Strategic Planning for Regulatory & Payer Success: We guide you through understanding the patient needs and payer perspectives, while ensuring your product meets all necessary regulatory standards.
- Real-World, Pragmatic Solutions: We provide actionable strategies that work in real-world scenarios, ensuring your product not only benefits patients but also generates a strong return on investment for your company.
Medical Information Services
Our Medical Team gives support for both promotional and non-promotional material across various indications. We ensure compliance with GPP and German and Austrian Medicinal Product Act while delivering expert medical reviews, systematic literature searches and approval and release processes to support your needs, as well as acting as Information Officer acc. to Medicinal Product Act (HWG) on client’s request.
GCP Training
We offer GCP, GVP, GPP and on request GMP, training and refresher courses tailored to the needs of small companies, universities and publicly funded organisations. Our trainings include Certifications and informed consent, ensuring compliance with best practices in Medical Research.
Contact us today to find out how LaNova Medical can help you.
Medical Device
MDR and IVDR Consultancy
We have deep expertise in medical device and diagnostics regulations, with extensive experience navigating the regulatory process for clinical trials and product approvals in the USA and EU.
Our clients benefit from our large collective experience when formulating and implementing regulatory strategies and study designs. Thanks to LaNova’s Medical flat management structure, this experience remains accessible and is never lost within a complex organisation.
Clinical Evaluation Services
We conduct or update scientific literature searches in line with the requirements of the MDR (EU) 2017/745 under consideration of the latest guidelines, which form the basis for a clinical evaluation.
Our experts first create a clinical evaluation plan ensuring that all the information we need for the report is available, following by creating the clinical evaluation report. To provide the required information and evaluations in a targeted manner, we apply the “clinical evaluation assessment report template”. We also consider the data of technically, biologically and clinically similar products to avoid gaps in the proof of suitability for the indications you have defined.
Person Responsible for Regulatory Compliance (PRRC)
With the introduction of the MDR and IVDR, the authorized representative is considered an economic operator and is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
The Medical Director of LaNova also acts as PRRC for some our of clients under the MDR and IVDR.
QMS implementation
We provide strategic compliance consultancy at every stage, helping SME Medical Device companies through all stage gates towards and beyond commercialization, consulting with them on anything that will impact the quality and compliance of the final product.
Our Quality Management Team also conducts internal as well as external audits, including those requested by clients.
Contact us today to find out how LaNova Medical can help you.
Combined Services
Biomedical Development
LaNova is a consultancy company in the biomedical healthcare sector providing expert guidance to spin-offs, start-ups, entrepreneurs and research centres.
With our expertise, we help entrepreneurs and researchers develop strong business plans and we support them during the private fundraising process.
Our areas of expertise include:
- Biopharmaceuticals
- Biotechnology
- Medical Devices
- In Vitro Diagnostics
- Digital Health
- Food Supplements
Medical Writing
We at LaNova offers Medical Writing of various documents related to healthcare and medicine, including regulatory documents, clinical trial reports, marketing materials, patient education resources, and scientific manuscripts. It involves translating complex medical and scientific information into clear, accurate, and accessible formats for different audiences, such as healthcare professionals, patients, and regulatory bodies.
Training
Clinical and Medical Research Professionals must possess the necessary skills, tools, knowledge and proficiency in project management techniques, clinical research and more specifically GxP.
Our training is delivered through:
- Multimedia presentations
- Case-based scenarios
- Practical resources tailored for real-world application
We strive to make learning effective, accessible and convenient, ensuring that professionals gain the knowledge they need with ease.
Providing Interim Management
We provide Interim Management as a temporary solution for Pharma, BioTech and Medical Device Companies for the following departments:
- Medical Affairs Department
- Clinical Operations Department
- Market Access Department
- Pharmacovigilance Department
- Quality Assurance
Interim management is defined as a short-term assignment of a highly experienced executive to guide organizations through periods of transition, crisis, or change. Our clients can expert that we will solve their problems promptly without long training periods.
Contact us today to find out how LaNova Medical can help you.