Cyton has a thorough knowledge of the key European regulations
that govern the specific aspects relating to OTC pharmaceuticals:
Directive 2001/83 as amended, Council Regulation 726/2004 and EMEA and ICH guidelines. These lay out the
data requirements and regulatory procedures that apply in
the European Union.
Quality/CMC
- Pharmaceutical and analytical development: strategic
advice and support
- Planning and managing development projects
- Experience with a wide range of pharmaceutical forms
- All aspects of the Module 3 of the CTD, including Generic
Applications, Drug Master Files, Certificates of Suitability
- Quality Overall Summary
Non-Clinical
- Pharmacological or toxicological development: strategic
advice and support
- Management of any comparative pharmacology or tolerance
studies
- Preparation of Module 4 of the CTD
- Non-clinical Overview and Summaries
Clinical
- Clinical development: strategic advice and support
- Management of Clinical studies
- Experience with a variety of therapeutic groups
- Preparation of Module 5 of the CTD
- Clinical Overview and Summaries
General Products
Cyton is able to provide regulatory guidance for some lifestyle
products that are consumer products that do not make specific
medical claims. General Products can nevertheless be products
that have one or more beneficial consumer lifestyle claims.
It is important to ensure that the appearance, presentation
and claims made for a General Product are therefore appropriate
and do not conflict with the guidance and legislation for
other product categories.
It is additionally important to ensure that the characteristics,
specifications and usage instructions are appropriate for
the target consumer of a General Product.
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