NEW REGISTRATIONS

We will support and advise you in your decision-making process with respect to the type of application and the registration procedure. We will help you to obtain authorisations as quickly as possible. We would be happy to work on your behalf as a marketing authorisation holder upon request and cover the relevant pharmacovigilance obligations. The entire procedure or any individual aspects of it can be taken of us at any time.


Type of marketing authorisation

  • Full application
  • Generic application
  • Hybrid application
  • “Well-established use” application
  • “Informed consent” application
  • Marketing authorisations and registrations of homeopathic products

Marketing authorisation procedures

  • National procedures
  • Duplicate procedures
  • EU procedures
    • MRP/DCP
    • Repeat use procedures
    • Line extension
    • CP

APPLICATION

Due to our international environment and our good contacts with the authorities, we are able to offer you a wide range of marketing authorisation Options.

DCP, MRP, RUP

We have used a large number of RMS, and all EU countries as CMS, in more than 500 procedures.

National procedures

We have carried out national procedures in most EU countries, as well as Switzerland, Serbia, Ukraine, Russia, CIS countries. A network of partners is available for processing specific national issues.

Centralised procedures

We are happy to handle centralised procedures for generics.

We compile marketing authorisation dossiers and manage the procedures in cooperation with our customers.

 


PREPARATION OF REGISTRATION DOSSIERS

We will be happy to reduce your workload in regard to compilation or review of your documents in accordance with the latest Guidelines and Directives and to prepare the marketing authorisation application for you.
  • Module 1 in accordance with the requirements for the respective marketing authorisation application
  • Quality overall summary (Module 2.3)
  • Non-clinical and clinical overviews and summaries (Modules 2.4 – 2.7), in cooperation with partners; including the specifications for impurities if applicable
  • Environmental Risk Assessment (Module 1.6.1)
  • Expert reports on orphan similarity (Module 1.7.1)
  • Assessment of elemental impurities
  • Processing fee payments to authorities
  • Requesting and incorporation of suppliers’ documents
  • Support with preparation of the product information
  • Translations
  • Organisation of readability tests
  • CMC writing
  • Biowaivers
  • Compilation of the dossiers in electronic and/or paper form

PROCEDURE MANAGEMENT

We manage your registration procedures in all phases and can act as your communications agent for your concerns vis-à-vis authorities.

  • Submission of the applications to authorities (e.g. via CESP or authorities’ portals)
  • Communication with the authorities
  • Supervision of formal validation
  • Advice on answering deficiency letters
  • Compilation of the response documents
  • Advice on conditions and commitments
  • National phase/translations
  • Review of the marketing authorisation documents
  • Variations
  • Tracking of deadlines and timelines

Depending on the assignment, we may deal with specific tasks and/or manage entire marketing authorisation packages in order to reduce your workload.


PHARMACOVIGILANCE

We have established a pharmacovigilance system and are therefore in a position to assume pharmacovigilance obligations for marketing authorisation procedures in which Kappler Pharma Consult GmbH acts as applicant up to the transfer of the marketing authorisation to the client.

We are also happy to advise you on the structuring of your pharmacovigilance obligations and the preparation of Risk Management Plans (RMPs) and SDEAs.