Regulatory House

Ensuring regulatory and pharmacovigilance compliance

We have built the Regulatory House as a safe place in the floating regulatory world. Our goal is to ensure regulatory and pharmacovigilance compliance for your company.

The year 2012, when new EU pharmacovigilance legislation was introduced, represented the biggest change to the regulation of human medicines in the EU since the year 1995. Regulatory changes are also running in other segments, such as cosmetics, veterinary products and medical devices.

Our team of Regulatory affairs and Pharmacovigilance Managers provide you with a competitive advantage to ensure your products are successfully registered and safely monitored all around the world.

We are able to meet your specific regulatory needs in the whole product regulatory lifecycle.

Regulatory House offers regulatory and pharmacovigilance services primarily in the area of medicinal products, cosmetics, veterinary products and medical devices.

We offer registration and pharmacovigilance services such as:

  • Registration Services
  • Registration Maintenance
  • MA holding Services
  • Notification Services
  • eCTD Publication
  • Establishing PHV System
  • PHV System Maintenance
  • Other Medical Services

Regulatory House blog

  • 3.12.2015 Supporting better use of medicines

    The European Medicines Agency (EMA) has released a draft scientific guideline that outlines how post-authorisation efficacy studies (PAES) should be designed by companies to support regulatory decision making in the European Union (EU). In addition, a guidance that describes the regulatory aspects for the fulfilment of imposed PAES is also published.

  • 27.11.2015 Mandatory payment of annual maintenance fees

    SÚKL informs marketing authorisation holders about their obligation to reimburse compensation of costs for SÚKL activities associated with the maintenance of medicinal product marketing authorisations by means of annual maintenance fees. 

  • 25.9.2015 PSUR Repository

    The PSUR Repository is now available and it offers a secure electronic submission point for Marketing Authorisation Holders (MAH), streamlining the Periodic Safety Update Report (PSUR) submissions for the pharmaceutical industry. 

  • 11.9.2015 Reprogramming cancer cells back to normal looks feasible, study shows

    In many respects, cancer is like a complex software program of life that has got out of control; instead of the code for normal cells, a code for making abnormal cells is executed.

  • 2.10.2014 EU Notified Bodies Update Code of Conduct

    The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms. 

  • 30.9.2014 Career

    Would you like to change your current work or are you looking for some new challenges? Do you need to see the results of your work? Are you ready to make own decisions and to take responsibility for them? You will have an opportunity to implement your novel approaches here. If you are aware that it is necessary to play by the rules, you may be our new team player in our company.

  • 4.4.2014 Career

    Would you like to relieve the monotony of your work and break from routine? Do you prefer doing things differently than the others? Do you need to see the results of your work and be personally committed? Are you ready to defend your decisions and bear responsibility for them? In our company you will have an opportunity to implement your novel approaches because creativity, results oriented approach, and responsibility, but also human values and employee satisfaction belong to our basic values. And if you are aware that it is necessary to play by the rules, you may be looking for a job with us.

  • 1.4.2014 Medical device to prevent hair loss in cancer patients

    It is well known that oncologic patients receiving chemotherapy often loose their hair.

  • 22.8.2013 Falsified Medicines Directive

    From 2 July 2013, all active substances manufactured outside of the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country confirming that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are equivalent to those in the EU.

  • 22.8.2013 Fees in EMA

    As of 4 August 2013 there are new rules for regulation of fees paid to EMA. Check up on fees payble for scientific advice, extension of marketing authorization, variations, inspections, administrative and other services.

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