Cyton Biosciences

Cyton Biosciences Germany

Cyton AH Biosciences GmbH
Konrad-Zuse-Ring 25
68163 Mannheim
Germany

We can provide your company with a comprehensive package of CMC and QA services, with a wealth of experience in CMC requirements for registration of standard dosage forms as well as those specific to veterinary medicine - including intramammaries, intraruminal devices and spot-on products

Our CMC services in brief:

• Pharmaceutical and immunological product development support
• Data audits and gap analyses
• Advice on product development and analytical method development
• Registration dossier writing
• Part 2 or CTD Module 3
• Detailed and Critical Summaries for Part 2
• Quality Overall Summaries
• Quality variations
• Responses to questions during Marketing Authorisation procedures
• CEP applications and ASMF procedures
• Viral risk assessment support for excipients of animal origin
• Comparative dissolution testing study design

Our GMP and QA services in brief:

• Development and Maintenance of QA Systems
• Creation and Implementation of SOPs
• SOP and QA System Audits
• cGMP Advice and Support
• GMP Auditing
• Quality system review

Preparation of technical dossiers to support Marketing Authorisation Applications

We use our experience 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 CMC 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 products from the initial concept up to registration. Our experience as independent regulatory consultants will ensure that the development process is accomplished efficiently and in compliance with regulatory requirements.

Gap analysis of data packages

A Cyton gap analysis 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 a wide range of dosage forms (including those specific to the veterinary sector). Our gap analysis reports include a high level overview of any deficiencies in your data package and a more detailed analysis of follow-up actions.

Preparation of Quality Overall Summaries (Detailed and Critical Summaries)

Our technical experts have in-depth knowledge of pharmaceutical manufacturing. Cyton can prepare critical summaries to support the chemistry and manufacturing data for new applications, Type II variations and renewals. Using our detailed knowledge of the 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 drawing on our long experience in managing Marketing Authorisation Application procedures. Cyton will work with manufacturing and testing sites to confirm regulatory compliance and ensure that responses submitted will meet the necessary 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 by supporting 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 critical reviews of Active Substance Master Files.

Quality Assurance and GMP support

Cyton’s Quality Assurance team can support clients in setting up or maintaining a Quality Management System with Standard Operating Procedures defining how work tasks are carried out. Cyton can help ensure you have fully controlled procedures - maintaining records of document versions, change history and scheduling regular system reviews. The QA team also has extensive experience in auditing SOP systems. We can help your company rationalise your systems and identify unnecessary duplication of activity, providing added value to our audit process.

Cyton’s QA team has experience in performing GMP audits for the manufacturers of Finished Products and Active Pharmaceutical Ingredients and distribution plants worldwide.

Meet our team

Cyton staff regularly attend animal health conferences, industry events and agency information days. If you are planning to go to such an event, check the 'Meet us at' section of our news page. We are always happy to meet current and prospective new clients, or talk informally to other professionals in industry.