Product Development, Dossier compilation and Life Cycle Management

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.

Human medicinal products

Benefit from our expertise resulting from numerous authorisation procedures for medicinal products with chemically defined active substances, phytopharmaceuticals and biologicals, carried out either in conjunction with our customers or independently on their behalf.

We will prepare the necessary applications and dossiers for the clinical trial and the marketing authorisation in CTD format, either in whole or in part. Regardless of the active substance and mode of administration, we will guide you effectively through the national or regional authorisation procedure. We are also happy to take care of communication with the authorities and project management in the authorisation procedure for you. The current regulatory requirements and your individual needs are of course considered.

Veterinary medicinal products

Veterinary medicinal products are not the same as medicinal products for human use: the regulatory framework conditions and requirements differ in many aspects.

We can also prepare the entire dossier for veterinary medicinal products – regardless of the active substance, mode of administration and authorisation procedure – in line with the latest regulatory requirements.

Product development

The efficient development of new active substances and products needs a regulatory strategy right from the start. We will work with you to develop this regulatory strategy and will accompany you through the preclinical and clinical development, right from the start.

We will create the dossier for your clinical investigational medicinal product (IMPD, IND) and can even take care of all of the project management activities if you wish.

A scientific advice meeting with selected authorities is almost always an important milestone in the authorisation project. Our experts will support you with the preparation, follow-up and implementation.

In addition, we offer you extensive analytical and technological services within the Tentamus group.

Active substances and excipients

No marketing authorisation/registration of medicinal products is issued without submitting dossiers on active ingredients and excipients. The competent authorities require comprehensive active-ingredient documentation that takes into account the extensive national and international regulations.

We have already prepared, updated and evaluated numerous active-ingredient dossiers (ASMF, CEP, US-DMF) and dossiers on excipients (CEP and US-DMF). These include:

  • Chemical active substances and excipients
  • Biological and biotechnological active substances and excipients
  • Herbal active substances and excipients

Life-Cycle Management

Once a product has been authorised or registered, the safety of the product must continue to be guaranteed and the quality information must correspond to the state of the art. In addition to the various responsibilities within the scope of pharmacovigilance, we can take over the processing of individual change notifications or the entire product support, as required.

Our Services

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


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.

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