Herbal Drugs

Herbal drugs are highly valued among the EU population. Strict legal requirements ensure consistently high quality, safety, and efficacy.

analyze & realize GmbH can provide the special knowledge, competent personnel and necessary contacts, particularly in the areas of natural raw materials and herbal drugs. We are experts in regulatory affairs of herbal drugs. Our team has experience in the pharmaceutical, biological, and medical fields. In the previous 10 years, we have participated in over 300 registrations of herbal drugs, primarily in Europe but also in the U.S.A. and Asia.

Product development

We develop herbal drugs according to the ‘Traditional Herbal Medicinal Products’ (THMP) or the ‘Well-established-use’ directives, as well as the German and European drug registration guidelines. We can also help with the development of completely new herbal drugs, including performing the required clinical studies.

For product development, we work closely with established laboratories for analytics and galenics, as well as with contract manufacturers. We can advise clients on patent questions as thoroughly as we do for the conception of business plans, including market analysis, strategy and concept development, including development of project plans as well as time and cost planning. 

 

Regulatory Affairs

In the area of regulatory affairs, we offer complete support in the registration procedure for herbal drugs or individual substances as well as custom services such as:

  • Gap analysis of texisting registration documentation
  • Strategic development of the appropriate registration procedure
  • Writing of registration dossiers (CTD/eCTD)
  • Expert reports
  • Traditional use documentation (for THMP)
  • Planning and organization of negotiations with drug authorities
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Pharmacovigilance

Our specialists will give comprehensive advice concerning the requirements of the authorities for drug safety that affect the life cycle of your product. The writing of PSURs (Perodic Safety Update Reports) is part of our services, together with complete literature research, and evaluation of scientific publications, which are necessary for the compilation of reports, dossiers, and expert statements.

Scientific Writing

Our services in the area of scientific writing include a wide portfolio. We can create the following for you in either English or German:

  • Scientific publications and reviews in national and international scientific journals
  • Brochures for scientific and marketing purposes
  • Expert reports
  • Registration dossiers (CTD)
  • Monographs
  • Product brochures
  • Books and multimedia presentations
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