The regulatory world is constantly changing. Whatever point your product has reached in its product lifecycle, it must adhere to its regulatory reality.
We help you to navigate the local and global regulatory environments, whether your product is a medical device, a pharmaceutical, a veterinary medicine, or a cosmetic product.
Our Regulatory Affairs Team has broad experience in product development, regulatory processes, technical documentation, and the submissions process when entering a new market.
We have experience from working with some of Sweden’s major suppliers across a range of risk classes and product classifications in medical devices and in vitro diagnostics.
The market entry process is typically expensive. However, we can help you to achieve savings in both lead times and costs by taking a long-term, strategic approach.
Our services cover several levels, depending on your needs. Our Regulatory Affairs team can assist by:
- Working alongside you in your processes
- Supporting you by setting up structures and training your organization in how to get started and work in these structures
- Managing your entire submissions process
We help you develop the appropriate level of relevant regulatory processes for your organization and make sure they are quality assured in terms of the applicable regulations.
When developing safe products it can be a major challenge to establish the right level of requirements specification, and to identify the correct standards and regulations/directives to follow.
By identifying correct requirements early on in the development process, your organization saves both time and money and can reach the market more quickly with a safe and approved product.
We have specialist capabilities in the area of CE marking and European regulations. We can help you with technical documentation, classification, specification, and identification of the standards and regulations that apply. We can also assist you in your contacts with authorities. You can include us in your internal product development project or outsource the entire CE marking process to PlantVision.
We can provide advice and support for regulatory affairs even during periods when you are not carrying out major projects.
By signing up to our Regulatory Affairs HelpDesk you can get expert advice whenever you need it. At the same time, you benefit from having a consistent support structure that is familiar with your operations and acts with your long-term interests in mind.
We can help you to establish a pharmacovigilance system, compliant with regulatory requirements affecting your business.
- Issuing standard operating procedures (SOPs)
- Issuing and updating a pharmacovigilance site master file (PSMF)
- Daily management of side effects
- Providing a qualified person (QP) responsible for pharmacovigilance (QPPV) and a deputy QPPV on 24-hour, 7-days-a-week availability
- Market intelligence/surveillance activities
- Periodic safety update reports (PSUR) and postmarket surveillance (PMS)
- Risk management planning (RMP)
- Training in pharmacovigilance
- Subscription service, including a subscription for updates of specific regulations and assistance in interpreting how changes in regulations affect your operations
- Internal review and inspections, including internal review of the pharmacovigilance system, and support and counsel before, during, and after external inspection by a governmental authority or customer
We guide you in the development of appropriate processes and documentation at the right level relevant to regulatory processes for your organization. We also make sure these are quality assured in terms of the applicable regulations.