Our working methodology

Before starting any engagement, the practice studies the documents provided by the client and sends a written fixed quote setting out the subject of the work, the document to be delivered, the timeline and the fee. This initial assessment is free of charge. Work is not billed by the hour, and the scope of an engagement is never extended without the client knowing and accepting it in advance. Where a matter requires the involvement of a scientific specialist, the scope and cost of that contribution appear separately in the same quote. This is not an isolated promise: it is the reason each service specifies from the outset which document is delivered and when.

The practice works at any stage of a product's regulatory life cycle, not only before it is placed on the market. Its specialisation lies in the preventive phase — reviewing before launch, so as not to face proceedings afterwards — but practice does not always allow the moment of entry to be chosen. Many companies seek a regulatory review precisely when they receive a request or a communication from the competent authority, which in Spain is usually that of the autonomous community. Matters therefore often arrive at this intermediate stage, rather than in the preventive phase or once a penalty is final.

Between those two extremes lies a procedure with distinct stages: initiation, investigation and the decision, against which the corresponding appeals lie. The practice can support the client at any of them: in the preventive phase, reviewing the product before launch; during the investigation, preparing submissions and providing the technical and legal documentation that supports the client's position; and, if the decision is unfavourable, preparing the corresponding administrative appeals. The practice's preference, and where its distinctive value lies, remains avoiding the later stages — but that does not rule out assistance once a matter has reached them.

Many of the questions that reach the practice cannot be answered by reading the text of a rule alone. Determining whether a health claim is authorised requires knowing the EFSA scientific opinion behind it, not only the regulation that lists it. Establishing whether an ingredient is a novel food requires assessing the available evidence on its history of consumption. Evaluating the risk that a borderline substance will be reclassified as a medicinal product requires reading pharmacological literature, not only case law.

Where the matter or the decision-making process requires it, the practice works with specialists in each field — medicine, clinical research, pharmacology, food supplement registration — who prepare signed opinions that become part of the overall solution.

Both the practice's reports and the opinions of the specialists who collaborate with it include a declaration of impartiality and objectivity — confirming that all relevant factors, favourable or not, have been weighed before reaching the conclusion — equivalent to the declaration that Article 335(2) of the Spanish Civil Procedure Act requires of an expert in court proceedings, even though the document is not intended to be used as evidence. It is the same standard of rigour, whether or not it ever reaches a court.