• Menu
  • Skip to right header navigation
  • Skip to main content
  • Skip to primary sidebar

Before Header

Link Medical Research

CRO – Contract Research Organization

  • Home
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Experts
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
    • Other Services
  • Therapeutic areas
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Customer Testimonials
    • Our Memberships
  • News & Events
    • News
    • Events
    • Publications
    • Videos
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • LINK Team Testimonials
  • Search
  • Home
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Experts
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
    • Other Services
  • Therapeutic areas
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Customer Testimonials
    • Our Memberships
  • News & Events
    • News
    • Events
    • Publications
    • Videos
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • LINK Team Testimonials
  • Search

Top Content

Regulatory Affairs Services
Home / Solutions / Regulatory Affairs Services

Regulatory Affairs Services

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 thorough knowledge.

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 that enables the 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 of 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 in-housing 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, Germany and the UK, 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.

More detail
  • 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 Brochure 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 scientific advice. We support and manage clinical trial applications, as well as managing questions from 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.

More detail
  • 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
  • Clinical trial regulation (CTR) guidance

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 the 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.

More detail
  • Maintenance of your Marketing Authorisation (variations, renewals, etc)
  • Update and translation of product information documents (SPC/LAB/PL) including proof-reading of labeling 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 a 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 a 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 authorizations, for example:

  • Variations
  • Transfer of marketing authorizations
  • 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

Regulatory Strategies

  • Regulatory advisory services
  • Preparing gap analysis by assessing the suitability of available documentation, e.g. CMC data, pre-clinical data and clinical data in terms of quality and compliance with guidelines
  • Advising on the most appropriate application procedure (centralized, mutual recognition, decentralized or national) as well as the type of application (e.g. complete, bibliographic, generic, hybrid or traditional use) including EU applications
  • Regulatory product development plans for the pharmaceutical development phase, the pre-clinical phase, and/or the clinical phase
  • Preparation of Target Product Profile
  • 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
  • Support and use eCTD ready document templates

Translations

Our regulatory managers have experience from a variety of therapeutic disciplines. We focus on linguistic accuracy, as well as regulatory compliance with mandatory templates and national requirements, such as QRD templates and Blue Box requirements.  We also deliver high-quality scientifically accurate translations within a short timeframe.

 

Head of Department

Marianne Holst
EVP Regulatory & Safety Operations
Marianne is a Registered Nurse from Copenhagen and has more than 30 years of experience within clinical research, joining LINK Medical in 2011. For more than 10 years she worked in the pharmaceutical industry as CRA, Project Manager and Line Manager within various indications. For the last 19 years she has worked in CROs where she held the positions as Head of Clinical Research and General Manager respectively.

Contact via email

Related links

  • Clinical Trial Regulation (CTR) EU No 536/2014
  • Medical device
  • Quality assurance
  • Marketing Compliance
  • Ethical marketing: The rules of medicinal product promotion – Article
  • LINK Medical broadens its regulatory consulting business in Sweden to help more companies navigate the regulatory framework- Article
  • LINK Medical expands its regulatory services team, strengthening its IMPD & CMC capabilities -Press Release

Primary Sidebar

  • Solutions
    • Early Clinical Development
    • Clinical Development
    • Post-Marketing
  • LINK Advantage – Full Service CRO
  • Market Access & RWE
  • Medical Device
  • Medical Experts
  • Medical Writing
  • PV – Pharmacovigilance Services
  • Clinical Operations
  • Clinical Project Management
  • Quality Assurance Services
  • Regulatory Affairs Services
    • Marketing Compliance
  • Biometrics CRO Services
  • Strategic Advice Group
  • Other Services

Site Footer

Don't miss out on the latest updates

Be the first to hear our breaking news at LINK Medical

  • Home
  • Solutions
  • Therapeutic areas
  • About Us
  • News & Events
  • Contact
  • Careers
  • Search

© 2023 LINK Medical Research
Privacy Policy

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent. Read More
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_gat_gtag_UA_142237341_11 minuteSet by Google to distinguish users.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
nQ_cookieId1 yearAlbacross sets this cookie to help identify companies for better lead generation and more effective ad targeting.
nQ_userVisitId30 minutesNo description available.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
CookieDurationDescription
VISITOR_INFO1_LIVE5 months 27 daysA cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface.
YSCsessionYSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages.
yt-remote-connected-devicesneverYouTube sets this cookie to store the video preferences of the user using embedded YouTube video.
yt-remote-device-idneverYouTube sets this cookie to store the video preferences of the user using embedded YouTube video.
SAVE & ACCEPT
Powered by CookieYes Logo