Regulatory expertise with key local insights
To stay up-to-date and to keep on top of constantly evolving regulatory requirements, you need a CRO partner with local insights and optimal solutions.
With one of the largest teams of experienced Regulatory Affairs specialists in the Nordics, we are positioned to guide our customers through every phase of product development. We have gathered a competent team which enables timely delivery of high quality regulatory projects. We are highly flexible and can outsource specific services or provide full service solutions to our customers. We have more than 25 years experience working in this field and have built a solid reputation founded on our integrity, delivering exactly what our customers need, when they need it.
Competence is key
At LINK Medical, our Regulatory Affairs specialists provide full-service solutions for all our customer’s regulatory needs related to human and veterinary products, also including medical devices, medical gases, herbal medicinal products, food supplements and cosmetic products. Customers can take advantage of our flexible approach, outsourcing specialist services or inhousing regulatory specialists for both short-term and complex projects. Our services include regulatory strategies, gap analysis, preparation of dossiers, eSubmissions, review of marketing material, translations and life-cycle management.
To learn more about how our Regulatory services can help you navigate the route to market with confidence, contact our Head of Department, Marianne Holst, at marianne.holst@linkmedical.eu.
Overview of Regulatory services:
Early Development
Through our unique network of Regulatory Affairs experts located in all Nordic countries, we can help you manage every regulatory challenge with confidence. We offer a variety of early development services and support including regulatory planning and gap analysis, scientific advice, CMC, preparation of the IMPD, IB and compilation of the regulatory dossier.
- Regulatory gap analysis and review of regulatory documents
- Regulatory strategy support and guidance
- Regulatory scientific advice
- Compilation and submission of the Regulatory dossier
- Clinical and medical Regulatory support
- CMC support
- IMPD support
- Investigator Broschure preparation
Read more about our full Early Development services.
Clinical Development
LINK Medical offers regulatory support and expertise throughout the clinical development phase of your product. Our experienced regulatory team can assist and support you with regulatory advice for clinical trial planning and can also help you prepare for a scientific advice. We support and manage clinical trial applications, as well as managing questions from the Competent Authorities. We also offer regulatory support in relation to CMC compliance and IMPD writing. With us as your strategic partner, you will receive the competent regulatory support you need to confidently navigate clinical development.
- CMC Compliance
- IMPD preparation and review
- Investigator Brochure
- Briefing package preparation for regulatory scientific advice
- Regulatory input to and submission of Development Safety Update Report
- Submission of Clinical Trial Application including review of documentation
Read more about our full Clinical Development services.
Post-Marketing:
LINK Medical will support your Regulatory maintenance during your product lifecycle. We provide a complete range of services needed for a successful preparation, compilation and submission of your updated dossiers. We are an experienced partner that can facilitate contact with Competent Authorities and Notified bodies during the maintenance phase of your products. LINK Medical will assist you in developing your post-approval strategies.
- Maintenance of your Marketing Authorisation (variations, renewals, etc)
- Update and translation of product information documents (SPC/LAB/PL) including proof-reading of labelling and artwork
- Translation of educational material
- Can act as your first contact to National Competent Authorities and Notified Bodies
- Consultation and advice on national legislation and specific requirements
- Periodic safety update reports (PSURs)
- Risk Management Plans (RMP)
- Maintenance of FASS and Felleskatalogen
In addition, we can also assist you with review of marketing material according to national pharmacodes. Read more about our full Post-Marketing services.
Detailed service list:
Dossier preparation:
- Chemistry, manufacturing and control (CMC) documents, including quality overall summaries (QOS)
- Pre-clinical overviews and summaries
- Clinical overviews and summaries
- Product information texts, including summary of product characteristics, package leaflets and label texts
- User/readability testing of package leaflets
- Managing source documents in a secure and web based regulatory Document Management System (MasterControl). Possibilities for external access
Product life-cycle maintenance work:
We take care of all the steps involved in maintaining marketing authorisations, for example:
- Variations
- Transfer of marketing authorisations
- Renewals
- Periodic safety update reports (PSURs)
- Risk Management Plans (RMP)
- Updating summary of product characteristics (SPCs), label texts and package leaflets
- Proof-reading of labels and leaflets
- Catalogue texts, such as Felleskatalogen or FASS
Translations
- We focus on linguistic accuracy, as well as regulatory compliance such as quality review of documents (QRD) templates. Translation tools can be used if required by customer.
Regulatory Strategies
- Regulatory advisory services
- Assessment of suitability of available documentation, e.g. chemistry, manufacturing and control (CMC) documents, pre-clinical data and clinical data in terms of quality and compliance with guidelines
- Choosing the most appropriate application procedure (Centralised, MRP, DCP or National) as well as the type of application (e.g. complete, bibliographic, generic, hybrid or traditional use)
- Establishing product development plans for the pharmaceutical development phase, the pre-clinical phase and/or the clinical phase
- Preparation of pre-submission meetings and scientific advice/protocol assistance
- Rx-to-OTC switch strategies
eSubmission
- Compile, publish and validate eCTD and VNeeS submissions in Europe
- Fully Electronic submissions via portals (CESP, EMA Gateway)
- Granularity of documents for eCTD
- Access to eCTD compliant document templates
- Converting Non-eCTD electronic format (NeeS or paper) to eCTD format
Head of Department
