Cyton's office in Germany is ready to support the animal health industry
The new Cyton office in Mannheim, Germany guarantees our full range of EU services into the future. Communication and co-working between our technical departments and regulatory personnel is exceptional, and you can be assured that your project will get the attention and focus it deserves. Our in-depth knowledge of the legislation and guidelines can afford companies comprehensive regulatory solutions. The quality of the services we provide means that our clients come back to us again and again.
Post-Brexit business continuity for Cyton and our clients
The exact details remain unclear as to what the relationship will be between the EU and UK after March 2019. However, with the EMA and many national regulators advising industry to prepare for a hard Brexit, Cyton’s German office allows us to offer companies from outside the EU, including the UK, key services for business continuity
Specifically, the EU Qualified Person responsible for Pharmacovigilance (QPPV) must reside within the EU and there must be a site within the EU where all pharmacovigilance data is accessible. Just as Cyton’s UK office provides these services now, Cyton’s German office will continue to provide these services going forward, for any clients within or outside the EU who wish to outsource their pharmacovigilance responsibilities.
For full details of Cyton’s services relating to the UK’s withdrawal from the EU, please visit our Brexit webpage.
EU Regulatory Affairs projects
Our dedicated Procedures Group can assist your company with the initiation and day-to-day oversight of all kinds of regulatory applications, and their decades of cumulative experience adds value to our strategic advice. We can also offer proofreading and translation into English of scientific and technical documents by native speakers in German, Spanish, French and Turkish. We can even align our working practices with your own and act as an extra member of your regulatory team with our key person cover service.
- Dossier preparation, submission and regulatory procedures
- Marketing Authorisation Applications (MAAs), and all post-marketing activities for Veterinary Medicinal Products
- Feed Additive dossier preparation and submission
- Regulatory intelligence and strategic planning
- Life-cycle management
- Key person cover
- Borderline products
Full details of Cyton's services in regulatory affairs can be found in the link below.
Manufacturing and CMC / quality projects
Writing the chemistry, manufacture and control documents required for the EU VMP dossier is second-nature to our highly skilled team. From product development to post-marketing changes, we know what the regulators ask for and how best to present your data.
- Dossier writing, including Part 2 of the Notice to Applicants veterinary dossier (NtA) and Module 3 of the Common Technical Document ‘human’ dossier (CTD)
- Detailed and Critical Summaries (DACS) and quality expert opinions
- Active Substance Master Files (ASMFs) and Certificate of Suitability (CEP) dossiers
- Responses to questions during MAAs and other regulatory procedures
Full details of Cyton's services in CMC can be found in the link below.
Safety requirements for veterinary medicines in the EU can be a challenge to meet, especially environmental risk assessments for food-producing animals. Cyton surpasses the competition in this area, as we are able to draw on our internal connections with the wider knoell company. With an in-depth knowledge of toxicology and user safety requirements, we can ‘cover all bases’ for the safety dossier.
- Toxicology, User Safety and Environmental Risk Assessments (ERAs)
- Dossier writing for Part 3A and Part 3B of the NtA format
- Maximum Residue Limit (MRL) dossiers
- Expert opinions and responses to questions
Full details of Cyton's services in safety projects can be found in the link below.
Preclinical & Clinical projects
With expertise always on hand from qualified veterinarians, your pre-clinical and clinical projects are in safe hands. From writing Part 4 dossier sections, expert opinions and responses to clinical questions, to review of protocols, placing studies and writing up reports from the raw data: Cyton’s clinical team adds value at every stage of product development through to registration.
- Writing the preclinical and clinical dossier sections (Part 4)
- Detailed and Critical Summaries and clinical expert opinions
- Editing and proofreading of study protocols
- Clinical trial applications in Germany
- Clinical study report write-up (GSP, GCP, GLP)
- High-level medical writing by qualified veterinarians
Full details of Cyton's services in preclinical and clinical projects can be found in the link below.
Product safety concerns don’t stop with the issue of the Marketing Authorisation, and pharmacovigilance is a key aspect of the MA holder’s post-marketing obligations. Cyton can provide a complete PV service for companies: including QPPV both in the UK and within the EU post-Brexit.
- Preparation and submission of Periodic Safety Update Reports (PSURs)
- Independent systems audit and inspection preparation
- Electronic reporting and EudraVigilance support
- In-house staff training
- Fully outsourced PV system, including provision of the EU Qualified Person for PV (QPPV)
- Preparation or critical review of the Detailed Description of the PV System (DDPS)
Full details of Cyton's services in pharmacovigilance can be found in the link below.
Quality Assurance (QA) & Good Manufacturing Practice (GMP)
GMP standards must be upheld for any veterinary medicinal product on the EU market, and inspections of manufacturing facilities by the competent authorities can be a source of worry. As well as creating and reviewing QA and SOP documents to ensure compliance, Cyton can provide on-site assistance in the form of pre-inspection GMP audits to help avoid critical issues on the day.
- Development and Maintenance of QA Systems
- Creation and Implementation of Standard Operating Procedures (SOPs)
- SOP and QA System Audits
- cGMP Advice and Support
- GMP Auditing
- Quality System review
Full details of Cyton's services in QA and GMP can be found in the link below.