For the field of “regulatory affairs” we offer numerous services which can be called upon in a project-oriented way.
Overview of services
The production of approval dossiers and the management of approvals can only be performed by specialists. We carry out regulatory tasks in cooperation with a network of specialists who are especially familiar with the respective local and (inter)national conditions.
For the field of “regulatory affairs” we offer numerous services which can be called upon in a project-oriented way:
Regulatory consultation for defining the right strategy for approval applications and variations
Regulatory consultation in product development (pharmaceuticals, active agents and excipients)
Production of expert reports
Production of (non-)clinical overviews and quality overview summaries in accordance with the current European regulatory requirements
Designing of the dossier
Production and maintenance of the dossier in CTD/eCTD format
Carrying out of approval, registration and renewal procedures
from the production of the necessary documents to the granting of ap-proval (national, EU-wide (MRP/DCP/CP) and Switzerland)
Production, processing and submission of variations in accordance with Variation Guideline and according to § 29 AMG
Production and maintenance of the ASMF
Production and maintenance of drug master files
Making of Certificate of Suitability (CEP) applications and revisions
from the production of the necessary documents to approval according to current EDQM directives
Regulatory evaluation of the quality and completeness of an existing product dossier and its compliance with current regulatory requirements and the current scientific state of the art
Pharmaceuticals, like all products, are subject to a product lifecycle. This already starts during development (including pre-clinical trials, clinical trial phase 1, etc.), extends to the application for a new registration and ends with the de-registration of a product. During the product lifecycle work continually has to be carried out for the retention and widening of the approval. This includes for example: variations for the reporting of a new active agent manufacturer or for the alteration of information texts. Before implementation in production, approvals have to be obtained from the responsible authorities regarding the underlying variations. We provide support in every phase of the product lifecycle. For this, you can decide whether we support you in individual projects or comprehensively in complete lifecycle management.
In the implementation, we talk with manufacturers, suppliers, logisticians and authorities for you and together with you we find targeted solutions, to shape the lifecycle of your product efficiently and safely.
We have in the past gathered a great deal of practical knowledge in many different projects, so our aim is to suggest to you not just purely formal solutions, but solutions that bear in mind your product as a whole. It is crucial for us that changes to the dossier of your pharmaceutical also leave scope for future developments and do not increasingly restrict the possibilities for action over time.
Approval applications, renewals and variations
In the field of regulatory affairs we offer you the whole range of tasks. This includes approval applications, renewals and variations of types IA, IB and II. We can carry out submissions for you EU-wide and in Switzerland.
We will save the pharmaceutical dossier of your products on our IT system free of charge. In addition to this, we will make your data available to you via a secured data exchange box, in accordance with the highest TCDP protection class III, for longterm archiving in your storage systems.
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