• Regulatory Affairs
  • Medicinal products

Medicinal products

The pharmaceutical quality, efficacy and safety must be guaranteed to obtain a drug marketing authorisation. We know the specific requirements and can lead your projects to success.

Medicinal products for human use

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. 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 NTA format and 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 strategy for your candidates and will accompany you through the preclinical and clinical development, right from the start.

We react flexibly to your needs and will advise you on the basis of our many years of experience in development projects. 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.

In addition, we offer you extensive analytical and technological services within the HWI 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
  • Biological active substances
  • Plant extracts/herbal active substances
  • Excipients

 

Our services:

CTD preparation

We can prepare and update your authorisation dossier:

  • Module 1 with the administrative details according to regional requirements, even if you submit everything yourself
  • “Quality overall summary” (QOS, CTD Module 2.3) and the corresponding Module 3
  • “Non-clinical overview”, “the tabulated and written summaries” (CTD Modules 2.4 and 2.6) as well as the corresponding Module 4
  • “Clinical overview”, “the tabulated and written summaries” (CTD Modules 2.5 and 2.7) as well as the corresponding Module 5
  • Documentation for traditional registration including preparing evidence of traditional use for phytopharmaceuticals
Application for clinical trials

We will prepare the required documents for clinical trials (IMPD, IB, IND for US-FDA) and submit the application to the competent authorities on your behalf.  This also includes substantive amendments in the course of the study.

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 can 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.

Dossier reformatting

Do you still have a dossier in the old NTA format and need to transfer it into CTD format? Does your dossier need to be revised according to different regional requirements (e.g. US QOS vs EU QOS)? We are reformatting your dossiers.

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)

Take advantage of our expertise from a large number of successful procedures.

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

As the holder of the marketing authorisation, you need to continually keep your dossier 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 and 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
  • 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.

Contact us. We’re happy to help!

Dr. Andrea Klüting
Vigilance & Regulatory Affairs
Business Development HWI group

Phone: +49 89 2000203-60
Email:

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Dr. Jürgen Epple
Quality/CMC

Phone: +49 89 2000203-95
Email:

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0