Regulatory Affairs

Regulatory Affairs

At EL PHARMA Representation Services of PHOENIX group, we are committed to delivering Regulatory Affairs services that adhere rigorously to both European and local legislation, guaranteeing compliance for all products under our management.

What our Regulatory Affairs Services Include

Marketing Authorisation Holder Services from regulatory strategy and application to post-approval lifecycle management in non-EU PHOENIX markets.

Local representative on behalf of partner including:

  • Point of Contact with Authorities
  • Regulatory Intelligence
  • Product Information management
  • Management of the regulatory approvals for repackaging activities and supply of non- registered/foreign packs to the market
  • Management of the regulatory approvals for advertising and promotional materials, etc.

Full Regulatory affairs services from regulatory strategy to lifecycle management in non-EU PHOENIX markets.

Why choose us

Expertise and Innovation in Pharmaceutical Industry

Team and expertise

Whether it is navigating complex regulatory requirements or providing guidance on compliance matters, our dedicated team is equipped to assist at every stage of the regulatory process.

Partner with us

Make a Difference

With extensive track of records in successfully serving partners across pharmaceutical industry, we are committed to bridging the healthcare gap across Europe.

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This website uses cookies.

We use cookies to personalize content, provide social media features, and analyze traffic to our website. We also share information about your use of our website with our social media, advertising and analytics partners for their own processing. You can find out which cookies are used for which purposes and for how long under “Show details”. For information on which personal data processing is pursued with the respective purpose, please refer to our privacy notice. By clicking on “Allow selection” or “Allow all cookies”, you consent to the setting and accessing of cookies or similar technologies on your end device with which you visit our website, as well as to the processing of personal data associated with the respective selection. At the same time, you consent pursuant to Art. 49 (1) sentence 1 lit. a) GDPR to your personal data being processed by the respective services in third countries in accordance with your selection. Please note that in the third countries to which your data is to be transferred on the basis of your consent, there is no level of data protection comparable to the GDPR. There is therefore a risk, among other things, that you may not be able to effectively exercise your data subject rights or that your data may be processed by state law enforcement authorities or by other third parties contrary to the requirements of the GDPR. You can withdraw these consents at any time with effect for the future by deactivating the use of cookies via your browser settings.

Privacy notice              Imprint

 

Cookies are small text files that can be used by websites to make a user’s experience more efficient.

The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission.

This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.

You can at any time change or withdraw your consent from the Cookie Declaration on our website.

Learn more about who we are, how you can contact us and how we process personal data in our Privacy Policy.

Please state your consent ID and date when you contact us regarding your consent.

Your consent applies to the following domains: elpharma.hu


Cookie declaration last updated on 2025. 05. 06. by Cookiebot:

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Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.

NameProviderPurposeMaximum Storage DurationType
CookieConsentCookiebotStores the user’s cookie consent state for the current domain1 yearHTTP Cookie
elementorelpharma.huUsed in context with the website’s WordPress theme. The cookie allows the website owner to implement or change the website’s content in real-time.PersistentHTML Local Storage
rc::aGoogleThis cookie is used to distinguish between humans and bots. This is beneficial for the website, in order to make valid reports on the use of their website.PersistentHTML Local Storage
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Marketing (2)

Marketing cookies are used to track visitors across websites. The intention is to display ads that are relevant and engaging for the individual user and thereby more valuable for publishers and third party advertisers.

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