The regulatory environment is complex. Our experts understand how to achieve a smooth route to market by balancing the client’s needs for their product with what is possible within the regulations. We can help you anticipate likely points of contention, support your plans to address these and minimise the risk of failure before you submit your dossier.

knoell can provide:

• Strategic regulatory advice throughout your product’s development
• Briefing documents and expert representation at regulatory authority meetings
• Expert reports and detailed and critical summaries (DACS)
• Preparation of technical and supporting documents to the required specifications, and submission to the authorities
• Parallel Scientific Advice for the EU and USA
• Regulatory and technical due diligence
• Applications for clinical studies or Maximum Residue Limits (MRLs)
• Production and tech-transfer support
• Comprehensive post-marketing support
• Minor Use, Minor Species (MUMS) / Limited Market guidance
• Best route to market advice on non-registered / ‘borderline’ products
• Regulatory affairs training tailored to your requirements

Whether you are looking to carry out a single study during the development of your product or you are looking for a partner to whom you can outsource the complete drug development process, the animal health team at knoell has the expertise and experience to support you.

The drug development process is not cheap and knoell understands the pressures in what is an increasingly competitive industry. With knoell as your partner, you can be sure that the data you generate for your product will be fully compliant with all regulatory requirements, without incurring unnecessary expense.

If you are not looking to outsource the complete drug development process for your products, knoell can provide the following specific services:

• Gap analysis and data audit for your product identifying supported claims and additional data requirements
• Conducting literature searches and evaluation of published data to support your product’s development and registration
• Preparation of development plans with estimates of costs and timelines
• Study design and reporting in compliance with all relevant guidelines
• Preparation of User Safety Risk Assessments (USRA), as required for all EU product licence applications
• Preparation of Environmental Risk Assessments (ERAs) - both Phase I and complex Phase II
• Maximum Residue Limit (MRL) dossiers and withdrawal periods
• Independent selection of Contract Research Organisations / Contract Manufacturing Organisations to conduct studies, and associated Sponsor Representative support
• Product development and manufacture  strategic advice and support

Read more on product development

knoell is a leading provider of veterinary clinical study expertise. Our experience ranges from small single site to large multi-national studies in both companion and food animals. At knoell, we work with you to ensure that each study is specifically tailored to your needs. VICH GCP trained monitors have excellent local knowledge and provide support for our extensive network of experienced veterinary investigators.

knoell also offers a VICH GCP managed trials service. Using their in-house veterinary team as investigators, this approach is ideally suited for studies that require frequent (i.e. daily) samplings and data recordings.

Whether you require studies to confirm clinical efficacy, field safety, dose confirmation, serology or post-marketing surveillance, we provide:

• Expert advice on planning and design
• Protocol and data collection form development
• Site selection, laboratory identification and management
• Trial clearance approval
• Management of adverse events and pharmacovigilance
• Study set-up and study file preparation
• Investigational veterinary product and control product management
• Multi-lingual service
• Investigator selection and training
• Close monitoring and regular site visits
• Independent quality assurance at all phases
• Data management
• Statistical analyses and interpretation
• Final study reports

The pressure to ensure drug safety increases every day and effective implementation of Pharmacovigilance procedures is becoming ever more critical for Animal Health companies. The multilingual and multi-disciplinary veterinary and regulatory team at knoell can assist you in keeping up to date and compliant with the latest Pharmacovigilance regulatory requirements and can oversee the complete process on your behalf.

We can offer:

• Compilation of data exchange contracts
• EU QPPV and deputy
• Receipt, processing, review and follow-up all adverse event reports
• Pharmacovigilance Standard Operating Procedures tailored to your exact requirements
• Compilation of the Detailed Description of a Pharmacovigilance System for inclusion in Part I of your dossier
• Management of serious adverse events
• Ad hoc support to cover staff absence
• Expedited reporting to local authorities and reference member states
• Compilation, review and submission of aggregate reports (e.g. PSURs)
• Signal detection activities and continuing evaluation of the risk/benefit balance
• Pharmacovigilance training
• Maintenance of a safety database and paper records
• Electronic reporting in the EU and UK, including registration support for EVvet and VMDS
• Surveillance of published literature
• Help with preparation for Pharmacovigilance audits and inspections
• Pharmacovigilance in clinical trials of investigational veterinary products

Quality Assurance is an essential element of animal health product development, whether in pre-clinical studies, clinical studies, pharmacovigilance or manufacturing.

Read more to find out how our trained QA auditors can support you in meeting the principles of Good Laboratory Practice (GLP), VICH Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

Whether you are interested in chemically defined feed additives, micro-organisms, enzymes, or medicated feed, with knoell on your team you can be confident of clear understanding and proven interpretation of the Regulations and Directives, meaning your product will meet with marketing approval more quickly.

Our specialist services and expertise for animal feed and feed additives are based on the following product types: Feed Additives (technological additives, sensory additives, nutritional additives, zootechnical additives, Coccidiostats & Histomonostats), Premixtures, Feed materials, Compound feed, Medicated feed and PARNUTs (“dietetic” feed).

Our services include:

• Strategic advice (product classification and legal basis)
• Labelling review and preparation that complies with EU requirements
• Data audit and gap analysis
• Dossier preparation (administrative and technical)
• Submission of applications and management of procedures
• Liaise with the European Commission, EFSA, EURL and National Competent Authorities
• Financial planning (assistance in estimating costs and tendering required studies)
• Design and organise animal studies to be included in EU dossiers with an established network of CROs
• Field trial clearance approval
• Review or help develop methods of analysis for additive, premixtures, animal feed and residues in tissues with reference to EURL requirements
• Life cycle management of projects
• Consortium management (for authorisation of additives, MRLs, etc.)
• Marketing strategies

With established clinical teams in the US and Europe and over 750 years of combined animal health experience, as well as affiliated offices in Asia, the knoell Animal Health team is able to seamlessly coordinate projects in multiple geographies, from proof of concept to registration and beyond, balancing the pillars of quality, time, and budget.

Optimise the way you perform your day-to-day work. Automation can help.

The withdrawal of the UK from the EU has increased the regulatory complexity for the animal health industry in Europe. With animal health teams in both the EU and the UK, knoell can offer our clients a full range of services in product development and regulatory affairs to meet the requirements of both regions. Some specific examples of where the team can provide support include:

• Consolidation of EU dossiers for UK national Marketing Authorisation applications
• Marketing Authorisation transfers
• Product literature updates
• Batch control and batch release site variations
• Pharmacovigilance support, including QPPV for the EU and the UK
• Transfer of MUMS classification status
• Regulatory submissions to the EMA, EFSA and the National Competent Authorities in the EU; and UK Veterinary Medicines Directorate and Food Standards Agency in the UK