Overview | Lifecycle Management | Pharmacovigilance

We specialize in all aspects of licensing herbal products as medicines, food supplements and cosmetics. We advise manufacturers on registration of their products in European, North American and Pacific markets. We offer services ranging from feasibility studies via assembling the registration dossiers and associated documentation for traditional herbal medicines (THMP), well established use (WEU) registrations and full market authorizations (MA). We help manufacturers with placing and establishing their products in new markets, take products through the registration process according to national requirements, assist with setting up a sourcing, contract manufacturing or distribution system or finding suitable distribution partners or businesses suitable for acquisition respectively.

Overview

• Ethnobotanical and Ethnopharmacological Plant Research
• Literature Research and Reviews
• Compilation of Plant Profiles
• Medical writing
• Plant Photography
• Tailor-made Content Management
• Translation Service
• Product Development and Sourcing of Raw Materials
• Product Placement, Distribution
• Product Management and Marketing
• Registration of herbal products according to national legislation
  • Traditional Herbal Medicinal Products (THMP)
  • Well Established Use (WEU)
  • Full Market Authorization (MA)
  • New Dietary Ingredients
  • Food Supplements
  • Cosmetics
• Support, guidance and preparation of all regulatory documents in CTD format
• Support, guidance and preparation of Quality Overall Summaries or Clinical Overviews
• Preparation of the Summary of Product Characteristics (SmPC)
• Preparation of patient information leaflets and user testing
• Submission and management of applications
• Interfacing with regulatory authorities
• Support and guidance with all post–approval activities, variations, renewals, PSURs etc.

Lifecycle Management

Once a product achieves approval from a national regulatory agency for a traditional herbal registration, or a marketing authorisation, this is the first step in the life of the product.

Continuous updating of the registration is required as the registration must be kept up to date with any changes in manufacturing or safety that occur. Examples of such changes are:

• switching to a different source of the herbs used
• a change to the manufacturing method
• a new manufacturer or packer of the finished product
• a change to finished product specification
• an extension to the shelf life
• a change to pack size or container type
• new side effects reported are added to the Summary of Product Characteristics (SmPC)
• Allowing another manufacturer to sell their own brand version of the product.

Such changes are required continuously to ensure that the manufacture and control of the product being carried out in particular are compliant with approved registered details.

We provide a regulatory affairs service that can advise you on potential changes and data requirements, through to assembly and submission of variation packages to any EU national Health Authority together with follow up until approval of the change is received.

Please contact us directly for more details.

Pharmacovigilance

Once a product achieves approval from a national regulatory agency for a traditional herbal registration, or a marketing authorisation, pharmacovigilance monitoring requirements must commence.

This is a legal requirement and all EU legislation must be complied with by a company. Pharmacovigilance inspections are routinely made by regulatory authorities to check that valid systems are in operation.

A pharmacovigilance system must be set up to capture, report and evaluate any potential adverse event reactions that become known to the company in connection with each herbal product registered.

A Qualified Person in Pharmacovigilance (QPPV) is required to take overall responsibility for the pharmacovigilance system of a company.

We can provide the necessary expertise to establish a pharmacovigilance system for you, to provide the services of a QPPV or alternatively if you prefer to outsource all pharmacovigilance activities.

Please contact up for an initial discussion about your requirements.