Regulatory Affairs für Arzneimittel

Das regu­la­torische Leis­tungsangebot der Tenta­Con­sult für Human- und Veter­inärarzneimittel bildet den gesamten Produk­tzyklus ab – von der präk­lin­is­chen Entwick­lung bis hin zu Post Market Follow-Ups. Unsere Exper­tise umfasst dabei chemische, biol­o­gische und pflan­zliche Wirk­stoffe und Hilfsstoffe.

CTD-Erstel­lung und Aktualisierung

• Modul 1 mit den admin­is­tra­tiven Daten entsprechend den regionalen Anforderungen, auch wenn Sie die Einre­ichungen selbst vornehmen
• “Quality overall summary” (QOS, CTD-Modul 2.3) und das entsprechende Modul 3
• “Nonclin­ical overview” und ​“Tabu­lated and written summaries” (CTD-Module 2.4 und 2.6) sowie das entsprechende Modul 4
• “Clin­ical overview” und ​“Tabu­lated and written summaries” (CTD-Module 2.5 und 2.7) sowie das entsprechende Modul 5
• Unter­lagen für tradi­tionelle Registrierungen, einschließlich der Erstel­lung eines Tradi­tions­beleges für Phytopharmaka

Beantra­gung klin­is­cher Studien

Wir erstellen die nötigten Unter­lagen für die klin­ische Prüfung (IMPD, IB, IND für US-FDA) und reichen den Antrag bei der zuständigen Behörde für Sie ein. Dazu gehören auch ​„Substan­tial Amend­ments“ im Laufe der Studie.

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.