Services for Marketing Authorization Holders of Pharmaceutical Products

Histros Ziviltechniker Ges.m.b.H. provides regulatory affairs services for new products in the development process and for already marketed products, for instance in the course of renewals or in the case of profound changes.

The company offers customized solutions. The client can select from a bundle tasks, which will be designed and adapted exactly according to his needs and own business structure. In this way the client can rely on the high flexibility of Histros Ziviltechniker Ges.m.b.H.

The set-up of the projects need to be precisely planned by personal meetings in order to achieve optimal results. Examples of tasks, which can be conducted by Histros Ziviltechniker Ges.m.b.H., are:

✔ Development of the optimal regulatory affairs strategy

✔ Screening of regulations and their updates for EU member states and third countries in the CEE-region

✔ Training of personnel in drug regulatory affairs

✔ Planning and organization of scientific advice provided by the authorities

✔ Planning and project management for module 3 (quality)

- Liaison with the client´s manufacturing department and/or CMOs

- Liaison with the competitive authorities

- Acquisition of the required information

- Exchange of relevant information between the client´s laboratories, CMOs and responsible persons 

- Consultancy for the creation of documents required for the dossier

✔ Planning and project management for modules 4 and 5 (non-clinical and clinical studies)

Histros Ziviltechniker Ges.m.b.H. cooperates in such cases with third parties for the creation of modules 4 and 5.

Advantages of Histros Ziviltechniker Ges.m.b.H as your partner

✔ International experience in the management of marketing authorizations in the EU and the CEE-region

✔ Right to represent clients at competent authorities and at court

✔ Overview of the regulatory activities in order to organize the projects and the respective measures

✔ Solution finding for complex tasks

✔ Experienced in:

    - drug regulatory affairs

    - pharmaceutical quality management

    - wholesale of pharmaceutical products and chemicals

✔ Strategic and entrepreneurial thinking

✔ Registered office in the European Union

✔ Network in Austria and the CEE-region

✔ Knowledge of Slavonic languages

The above mentioned services can be provided on the client´s site as well. Depending on the characteristics of the product and specific topics Histros Ziviltechniker Ges.m.b.H. is also prepared to cooperate with partners. Histros Ziviltechniker Ges.m.b.H. is pleased to offer tailored solutions and invites you for an unbinding initial conversation. Please do not hesitate to use the contact form or the contact data!