Lindeq is a medical consultancy specialised in high-quality and flexible solutions within pharmacovigilance, clinical safety, cosmetovigilance and medical device vigilance.
The people behind Lindeq are all experts within their respective fields. They keep up to date with the latest related news and are compliant with the latest regulations, always aiming to provide the best solutions to our clients, who range from small companies to multinational organisations.
Pharmacovigilance
For over a decade Lindeq has provided high-quality pharmacovigilance (PV) services. We cover all topics within this area, from establishing QPPV, SOPs and quality management systems to operational solutions including all aspects of pharmacovigilance such as risk management plans (RMP), signal detection, PSUR, case management and much more.
Clinical safety
For companies still in the clinical trial phase, Lindeq provides all aspects related to collection and management of initial safety data. At this early stage, we are already aware of upcoming pharmacovigilance requirements and begin preparing, for example, an RMP, making the approval phase as well as the transition from the pre- to post marketing phase as smooth as possible.
Medical device vigilance
Medical device manufacturers as well as developers of medical mobile applications have to have a medical device vigilance system in place. We offer:
- maintenance support
- incident handling with clinical assessment and reporting to authorities
- company core data sheet
- field safety corrective action and field safety notice
- all other medical device vigilance-related tasks.
Cosmetovigilance
Lindeq can either support clients with selected services or establish a complete cosmetovigilance system; from safety assessment and reporting to registration, and from responsible person to preparation and maintenance of the product information file (PIF), with an optional web-based solution. In addition, we can provide complete set-up and maintenance of the post-marketing system for serious undesirable effects.
Why choose Lindeq?
Individual and flexible solutions
Products, tasks, policies and company structures are never the same and so every client has individual requirements. In order to guarantee high service standards, Lindeq always tailors services to meet the client’s specific requirements and situations.
Expert consulting
Lindeq combines a wide range of experience and knowledge with a large amount of know-how. We merge the knowledge of various people with great experience within their fields and hands-on experience from the respective industry with our various network partners.
Compliance and quality
Lindeq performs all services in accordance with regulations and guidelines. We use our knowledge in the best interest of our clients and provide high-quality services, which are always delivered on time.
Lindeq is ISO 9001-2008 certified, assuring conformity with management system requirements and guaranteeing consistent quality.
For more information, please use the form below to send us your business enquiry.
