Preparation of technical dossiers to support Marketing Authorisation Applications
We use our experience gained over 20 years of regulatory consulting and our QA controlled template documents to ensure that the structure and content of your dossier will satisfy current legislation. Cyton has the technical expertise in chemistry, manufacturing and controls to work with manufacturing sites during the dossier preparation and throughout the registration process.
Managing development of pharmaceutical formulations and analytical methods
Working in partnership with a range of contract research organisations Cyton can manage the development of veterinary products from the initial concept up to the registration of the product. Our experience as independent regulatory consultants for the animal health industry will ensure that the development process is accomplished efficiently and in compliance with regulatory requirements. For more information about specific services our partners can provide, please follow the links below:
Cleaning validation
Analytical development and stability studies
Gap analysis of data packages
Our data audits will determine the most cost effective route to obtain a Marketing Authorisation in your chosen market and confirm the optimum regulatory strategy. Cyton has experience with a wide range of applications from novel drug substances to generics and we are familiar with the data requirements for all veterinary dosage forms. Our gap analysis reports include a high level overview of deficiencies in your data package and a more detailed analysis.
Preparation of Detailed and Critical Summaries (formerly Expert Reports)
Our technical experts have an in-depth knowledge of pharmaceutical manufacturing. Cyton will prepare Critical Summaries to support the chemistry and manufacturing data for new applications, Type II variations and renewals. Using our detailed knowledge of current regulatory guidance we can help to justify the data presented, whilst also identifying any deficiencies, in preparation for the assessment process.
Documentation for quality variations
Cyton has the regulatory experience and technical expertise to support you in maintaining regulatory compliance for manufacturing activities post approval. We can assist with classification of manufacturing variations and preparation of the documentation for variation submissions, including expert statements to support significant changes to chemistry, manufacturing and controls.
Preparation of responses to questions received from regulatory agencies
Our technical experts will prepare effective responses to questions using our experience in obtaining Marketing Authorisations over 20 years. Cyton will work with manufacturing and testing sites to confirm regulatory requirements and ensure that responses submitted will meet regulatory requirements whilst minimising the regulatory burden on manufacturing activities.
Review of confidential manufacturing and controls data
Cyton can accelerate the regulatory assessment process with our review of confidential manufacturing and controls data and our support for the Active Substance Master File holder with significant issues, including the justification for selection of starting materials.
Assisting our clients with API sourcing
Cyton’s technical experts have experience in API manufacturing and we are well placed to conduct a critical review of Active Substance Master Files.
Related pages
Analytical development and stability studies