Authorisation files prepared and maintained in the EU, and products taken through registration in Latin America, by someone who has evaluated files on the authority side. For animal health and nutrition companies that need a defined piece of regulatory work done, or cover when the team is short, at a fixed fee per procedure.
For holders of veterinary medicines under Regulation (EU) 2019/6. I take a defined block of work, or I cover a position in your regulatory team during a vacancy or a leave.
If your company is based in the United States or Canada, an EU authorisation requires a marketing authorisation holder established in the EU and a qualified person for pharmacovigilance who resides in the EU. I help you plan both alongside the dossier.
For veterinary medicines, biologicals and feed additives. I evaluated registration files at a Latin American veterinary regulatory authority, so I know how an evaluator reads a file and what triggers a query. I use that in every country of the region.
For feed additive and premixture companies working under Regulation (EC) No 1831/2003. I prepare the files and I keep an eye on the dates.
I also take on smaller pieces of work, on their own or inside these projects. Pharmacovigilance support, including QPPV cover. Scientific literature reviews. Regulatory documents in Spanish for Spain and Latin America, such as SPCs, labels and dossier sections. Market maps drawn from the Union Product Database.
I evaluated registration files at a Latin American veterinary regulatory authority. That is where I learned what an evaluator looks for first, what triggers a query and how a file should be ordered so it moves. Requirements differ from country to country, but the way a file is read does not change much. I work across the whole region, and for each country I tell you early what your product will need.
Veterinary medicines and feed products.
Veterinary medicines and feed products.
Veterinary products and feed additives.
Veterinary medicines and feed products.
Veterinary medicines and feed inputs.
Veterinary products and feed.
Veterinary products and feed.
Ask me about the country you have in mind.
You tell me what the product is and where the file stands. I read what you have and tell you what is missing and what the authority will ask.
Scope, timeline and a fixed fee for the procedure, in writing. Nothing is charged before you accept it.
I prepare the documentation in the authority's format and submit it, or hand it to your team ready to submit. You get a copy of everything.
Questions from the authority after submission are answered as part of the same fee. The person who prepared the file is the one who answers.
I am a veterinarian with a specialisation and a master's degree, based in Hamburg. I began in regulatory affairs at a Latin American veterinary regulatory authority, evaluating registration files, and then worked in regulatory affairs in EU industry, in veterinary medicines and in animal nutrition.
Today I work independently under the DGF Vet Solutions name, as a regulatory partner to companies whose teams have more work than hands. The person you write to is the person who prepares your documentation and answers the authority's questions. Nobody else takes over your file.
Every engagement is agreed in writing, with a defined scope, timeline and fee. Your documentation stays confidential, and I sign a confidentiality agreement before you share it if you prefer.
I work in English and Spanish, and I also speak German. In Latin America this matters, because the documents, the authority and the importer all work in Spanish.
Tick what you need, add your email and send. That is all I need to reply, within one business day.
What changed, what it means for your dossiers and renewals, and Latin American authority updates when they matter to European companies. Never more than one email a month.