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.
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.
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.