Regulatory consulting
VESO offers regulatory consulting services from proof of concept to registration and beyond. Our Regulatory Specialists aim to provide regulatory advice with a view to streamlining product development, reducing time to market and maximising return of investment.
Development projects have a higher probability of success if regulatory advice is sought as early as possible, i.e. at the point of proof of concept. Our Regulatory Specialists provide advice on all product types including vaccines (inactivated, live and recombinant), pharmaceuticals, bacteriophages, monoclonal antibodies, feed additives and animal health products.
To speak to one of our Regulatory Specialists please contact us for a no obligation and no fee initial discussion to see how we can help
Preparation of Strategic Development Plans
Development plans provide a strategic roadmap to streamline product development.
The benefits can include:
- Focussing resource
- Reducing costs
- Reducing time to market
The comprehensive report maps out what tasks need to be performed and considered, and in what order to develop a product. Development plans can be for one geographic region or can cover multiple geographic regions for products in which a joint development is planned. Planning the development of your product at an early stage in crucial to managing budgets and timelines effectively. They ensure critical steps are not missed.
Our Regulatory Specialists can prepare a strategic development plan based on your needs.
Strategic Regulatory Advice
We provide strategic regulatory advice with a view to streamlining product development, reducing time to market and maximising return of investment.
We understand that it is critical to have the correct regulatory strategy in place from the start and we can help you develop the best strategy to suit your product and needs. We can provide strategic regulatory advice on any aspect, common requests include:
- Registration route – fastest, most cost efficient etc.
- Selection of a Reference Member State (RMS)
- Application type – full, generic, generic hybrid etc.
- Data or fee reductions - SME classification, limited market classification, exceptional circumstances etc.
- Development strategy – see Preparation of Strategic Development Plans
Due Diligence
Do you have a project in mind, but you are not sure whether it's suitable or viable for your company? Have you been offered a unique investment opportunity but are not sure of its commercial potential? If so, we can help you.
We can help you appraise your business opportunity by providing expert regulatory advice on whether the product is likely to be acceptable from a regulatory perspective, this may include an assessment of:
- Starting materials and formulation
- MRL assessment
- Review of manufacturing processes
- Review of any preclinical and clinical data
- Evaluation of the commercial potential
Technical Writing
We are experts in writing technical documents for regulatory submission, including:
- Dossier sections for Quality, Safety and Efficacy
- Critical Expert Reports (CERs)
- Applications for Limited Market
- Scientific Advice
- Clinical Trial Applications (see Research Trials)
- Maximum Residue Limit (MRL) applications
- Import Tolerance Applications
- Codex Alimentarius applications
- Post-approval documents including Variations and Renewals
- Responding to regulatory questions during procedures
- Drafting SPC’s, labels and artwork
We have a track record of bringing new veterinary medicines to market. Our Regulatory Specialists have successfully completed all the above-mentioned procedures and have the skills to write succinctly, with attention to detail, combined with specific knowledge of the regulatory guidelines.
Dossier Compilation, Submission and Management
Once the technical information has been written, the data pack must be prepared and submitted electronically (in most cases) according to regional requirements. Building the electronic dossier is complex and can be administratively challenging. We are experts in building and submitting electronic dossiers. This means that dossiers are validated within the defined timeline so that procedures can start on time.
Our Regulatory Specialists can take care of everything including:
- Preparing all documentation for submission – checking file and folder names, document formats and source, hyperlinking files, creating compliant tables of contents.
- Preparing the administrative sections of the dossier, including the electronic application form and associated annexes, preparation of the product information and preparation of the expert reports (see Technical Writing)
- Successfully validating the submission in accordance with regulatory requirements
- Registering with the appropriate electronic submission portal
- Submission of the documentation via the correct electronic portal in accordance with regulatory requirements
- Dealing with any post-submission validation queries
- Liaising with the regulatory authorities on your behalf to manage the submission as the procedure progresses
- Managing the translation phase of procedures
Advice on Study Design
Trials for fish can be complex, with multiple factors to consider, including:
- Size of fish and life stage
- Water temperature
- Water source (fresh water or sea water)
- Number of fish / tanks required
- Route of administration
- Route of infection
- Appropriate challenge models
VESO have a proven track record for designing compliant trials for regulatory submission.
VESO is unique in that we have our own in-house contract research facility (Aqualab) that conducts fish safety and efficacy trials. This means that our Regulatory Specialists can work closely with Aqualab Study Director’s to design studies that comply with current regulatory guidelines. This partnership allows us to monitor the progression of studies in real time and to deal with any challenges as they arise.
Field Trial Applications
Do you need assistance in compiling the required documentation for an application to the Direktoratet for Medisinske Produkter (DMP) in Norway?
Field trials must be approved before any field trial can begin. The regulatory landscape can be complex and having experts on hand to prepare and submit the required national documentation directly to DMP on your behalf can save valuable time. Our Regulatory Specialists are highly experienced in preparing and submitting field trial applications to DMP and can liaise with DMP throughout the application process to ensure the application runs smoothly. Not only that, once approved, we can run local field trials for you. We have a highly experienced team of local experts in Norway who understand how to run and monitor GCP field trials in accordance with the regulatory requirements. VESO can help you source suitable sites, and we have established relationships with several commercial fish farms who are experienced in running regulatory field trials.
Do you have a question?
Contact us - we are happy to help.
