Ozempic® (semaglutide) is a glucagon-like peptide (GLP-1) receptor agonist indicated for the treatment of Type 2 diabetes in adults.
Finkler is an independent consultant company that has been offering first-class regulatory affairs and generic drug development services since 1996.
Led by a team of experienced professionals, Finkler offers customised regulatory affairs and development solutions to ensure fast and successful development, authorisation or maintenance of your products.
Our key services in regulatory affairs are strategic advice, documentation, regulatory project / submission management and lifecycle management / maintenance.
Strategic advice for regulatory affairs
We offer sound strategic advice for regulatory affairs. As part of our service we can work with you to develop suitable development strategies. These include:
- Regulatory strategies for Europe
- Pre-submission evaluation of technical data
- Planning and handling of agency meetings (including preparation of briefing documents)
- Due diligence for licensing projects
- Regulatory intelligence
Regulatory affairs documentation services
Our regulatory affairs documentation services include compilation of dossiers according to Common Technical Document standards (ectd and Nees according to current requirements). Other documentation services include:
- Chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part based on customers’ raw data
- Drug Master File: technical writing of EU Drug Master File
- Pharmacological-toxicological and clinical documentation: compilation of dossiers based on customers’ study results
- Preparation of SmPCs, patient leaflets and labelling
- Quality overall summaries
- Non-clinical summaries / overviews
- Clinical summaries / overviews
- Literature search in all relevant databases
Regulatory affairs project management and submission services
We ensure that your applications and dossiers meet the relevant requirements and that the documentation is prepared in a timely manner. We follow up with our customers’ internal departments and their external partners during all phases of the procedure.
We handle your decentralised and mutual recognition procedures as well as your national applications from submission to approval. Our team of experts can prepare answers to deficiency letters. We liaise with all national EU authorities and with the European Medicines Agency (EMA) at all stages of the procedure.
Regulatory maintenance and lifecycle management
For both variations and renewals state-of-the-art documents are needed to keep your products alive. We ensure that your updates are prepared according to recent EU requirements.
Generic drug development services
Our skilled team of pharmacists and medical doctors has many years of experience in the development of generic drug products within the EU. We understand that no two development projects are the same and that each customer has its own goals. This is why we tailor our services not only to meet or exceed EU regulatory agencies’ needs but also to meet specific customer requirements.
Our deep knowledge of regulatory affairs ensures that the achievements and results from development work are presented in an agency-friendly way, to ensure fast and successful approval.
Regulatory affairs training
We provide customised half-day to three-day seminars at our offices in Lörrach, Germany, or at the customer’s site.
Since regulatory affairs is our daily business the content of the programmes is based on real-world experience combined with theoretical background knowledge. Seminar options include:
- Introductory course for secretaries and administrative staff
- Introductory course for new DRA professionals
- Management briefing: regulatory affairs
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