Dossier preparation, submission and regulatory procedures

Dossier writing and compilation

Before you can sell your product, you need to have a licence (in the EU, termed a Marketing Authorisation). Getting to grips with the format and content required for application dossiers in the EU is a big task, but luckily Cyton personnel do this work every day.  We can carry out partial or complete dossier writing on your company’s behalf to take the pressure off. You can have confidence that we will produce high-quality, compliant documentation and deliver it to the deadline we have agreed with you. Our electronic dossiers are also fully compliant with the current VNeeS format as specified in the relevant EU guidelines.  As the European submission process moves closer to the single submission goal, we keep track of which territories still have requirements for a physical dossier submission, and all other relevant national requirements.

Marketing Authorisation Applications and other regulatory submissions

Cyton has prepared and submitted dossiers for full, bibliographic, generic, hybrid and informed consent applications, for a wide array of different veterinary medicinal product (VMP) types and pharmaceutical forms.  As well as initial MAA procedures, Cyton has experience of line extensions to add new species, new indications, and new strengths/formulations to existing MAs.  Our teams are fully equipped to handle all other types of post-marketing applications too.  For some of our clients, we act as a ‘regulatory arm’ or supplementary team member, and handle all of the routine work relating to their animal health portfolio.  Refer to our life-cycle management section and key person cover service to find out more.

The kinds of work we routinely support our clients with are listed below:

  • Marketing Authorisation Applications (MAA) via Centralised, Mutual Recognition, Decentralised and National Procedures
  • Variations, Line Extensions, Renewals and MA Transfers (see life-cycle management)
  • Maximum Residue Limits submissions (MRL dossiers)
  • Scientific Advice requests 
  • Periodic Safety Update Reports (PSURs)
  • Clinical Trial applications
  • Feed Additive dossiers, including compound feeds, PARNUTs, and zootechnical products (see Feed and Feed Additives)
  • Borderline product assessment applications
  • Minor Use Minor Species (MUMS) applications
  • Preparation of ASMF / DMF / EDMF dossiers
  • Preparation of CEP applications and updates

A regulatory consultancy you can rely on

The management of a European dossier submission process can become complex with translations into official EU languages, national administrative requirements and authority fee payments. Cyton can manage the complete dossier submission process via all required routes (CP, MRP, DCP, NP) and can act as point of contact with the National Competent Authorities, managing the regulatory procedure on your behalf, allowing you to use your time resources elsewhere.

Cyton’s team can organise all pre-submission actions, prepare responses to authority questions during the procedure itself (LoQ), liaise with EU authorities to ensure that assessment timelines are rigidly adhered to and complete all national requirements (such as linguistic review and checking compliance for mock-ups of the labelling and packaging) to ensure your product gets to market on time.  Having wide-ranging language capabilities (please refer to our Contact Page) can also be an asset to your company.  You don’t need to be a linguist to benefit from our skills either: we find that communicating with the regulators is greatly facilitated by speaking their language.

Our effective project organisation, coupled with excellent communication, means that our clients are kept fully informed of their projects’ progress, and puts them in control of their submissions at all times.

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