Regulatory Affairs for Medicinal Products

TentaConsult's regulatory services for human and veterinary medicinal products cover the entire product cycle - from preclinical development to post-market follow-up. Our expertise covers chemical, biological and herbal active ingredients and excipients.

CTD compilation and updating

• Module 1 with the administrative data according to the regional requirements, even if you make the submissions yourself
• "Quality overall summary" (QOS, CTD Module 2.3) and the corresponding Module 3
• "Nonclinical overview and Tabulated and written summaries (CTD Modules 2.4 and 2.6) and the corresponding Module 4
• "Clinical overview and tabulated and written summaries (CTD Modules 2.5 and 2.7) and the corresponding Module 5.
• Documentation for traditional registrations of herbal medicinal products (phytopharmaceuticals), including the preparation of a traditional record.

Application for clinical trials

We prepare the necessary documents for the clinical trial (IMPD, IB, IND for US-FDA) and submit the application to the competent authority on your behalf. This also includes "Substantial Amendments" during the course of the trial.

Scientific advice

We prepare scientific advice discussions with the authorities on your behalf. This means: We prepare the necessary documents, submit the applications, accompany you to the scientific advice with the authority and support you during the discussions and in the follow-up.

Dossier for multinational marketing authorisations

We advise how you can best create your dossier for multinational marketing authorisations – in terms of the content as well as strategy. We carry out the relevant adjustments and revisions that will make maintaining cross-regional marketing authorisations significantly easier.

Management of authorisations

We will support you with submitting the application and selecting a suitable authorisation procedure, as well as throughout the entire authorisation process, thus ensuring that you can bring your product to market maturity quickly and efficiently.

We are familiar with all types of applications (e.g. full application, generic, hybrid, well-established use or traditional registration) and have many years of experience with the different types of authorisation procedures:

European authorisation procedure:

• National authorisation procedure
• Decentralised procedure (DCP)
• Mutual recognition procedure (MRP)
• Centralised procedure (CP)

US authorisation procedures:

• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Biologics License Application (BLA)

Process and project management

We support you at every stage of the authorisation process. You decide at which point you would like our support – in parts or as a full package:

• Strategic consulting
• Scientific advice and regulatory advice discussions with the authorities (e.g. pre-submission meeting, pre-NDA meeting)
• Preparation of the marketing authorisation dossier
• Compilation of administrative application documents (Module 1)
• eCTD preparation – with external partner
• Submission to the marketing authorisation authority
• Interaction with the authorities throughout the procedure
• Processing questions from the authorities (assessment reports, deficiency letters, statements)
• Interaction with other involved parties such as contract manufacturers, laboratory service providers

Texts

We take care of creating and managing the labelling of your medicinal product – as well as the summary of product characteristics and instructions for use – within the context of the authorisation and life cycle management, and we ensure compliance with the latest regulatory requirements.

Do you wish to include additional patient information? We’d be happy to make some design suggestions.

Life cycle management

To keep your dossier continually up to date we carry out the necessary updates, changes and amendments, evaluate them and notify the competent authorities, thus safeguarding the marketability of your products.

In terms of life cycle management, we also undertake sub-tasks or complete sets of marketing authorisations under portfolio management with all the regulatory, analytical and technical activities required once the marketing authorisation has been issued.

Our life cycle management service includes:

• Regular review and update of the marketing authorisation dossier
• Preparation, submission and processing of the relevant change requests for the competent authorities (e.g. variations, including work-sharing procedures, change notifications)
• Planning and implementation of change control processes
• Evaluation and processing of deviations in, for example, procurement and manufacturing
• Extensions/renewal applications
• Monitoring and meeting deadlines

Due Diligence und Regulatory Compliance

For all the available documents in your development process, we’ll perform gap analyses, for example of:

• IMPD and IB
• Reports on non-clinical and clinical trials
• Plans and reports on the physical-chemical characterisation of active substances, production development, scale-up, stability, compatibility, formulation development, impurity profiles and stability of clinical investigational medicinal products

We compile the results from the early stage of the development process in regulation-compliant reports and evaluate them in terms of their technical suitability and regulatory compliance. You receive an in-depth, structured analysis that enables you to close any gaps identified and to create an action plan.

The review of regulatory documents also plays an important role in the context of licensing negotiations, the planned purchase or sale of marketing authorisations and funding rounds with venture capital investors. In doing so, you receive a vulnerability analysis of the documents on active substances and the finished product and a regulatory and strategic appraisal, taking into account the targets you specify.

Scientific information and advertising materials

Your scientific information material needs to be sound. Does it correspond to the legal regulations in all aspects? We check your specialist and direct-to-consumer advertising just as we do scientific presentations that you provide for your opinion leaders.