Regulatory representation in El Salvador
We manage the sanitary registration of medicines, cosmetics, supplements and medical supplies before the Sanitary Regulation Superintendent’s Office (SRS), from dossier review through the final resolution.
Our services
We work with manufacturers, marketing authorization holders, importers and distributors. If you are abroad, we take care of the entire local side; if you already operate here, we reinforce your team with the procedures that pile up.
Sanitary registration of pharmaceutical products before the SRS: innovative, multisource, biological and over-the-counter. Assembly and review of the dossier, pharmaceutical product certificate and Good Manufacturing Practices certificate, quality and stability information, labelling and package insert, renewals and post-registration variations.
Learn moreRegistration of cosmetic and hygienic products. Review of the quantitative and qualitative formula, verification of restricted and prohibited ingredients, permitted claims, labelling, certificate of free sale and manufacturer documentation.
Learn moreRegistration of nutritional supplements and related products. We start with the correct classification of the product before assembling anything. Then we review ingredients and doses, nutritional and health claims, the technical data sheet and labelling.
Learn moreRegistration of medical devices and wound-care materials according to risk class. Classification, evidence of conformity, certificates of free sale and of quality system, instructions for use, labelling and import permits.
Learn moreCross-cutting services
Our experience
We have managed more than 1,000 sanitary registrations for manufacturers, holders and importers from North America, South America, Europe and Asia. Along the way we learned something that keeps repeating: foreign companies do not fall behind here because of their product; they fall behind because of their dossier. An unapostilled document, an unevidenced power of attorney, or a query left unanswered on time stops a launch that was already technically ready.
Clients on four continents:United States · Canada · Mexico · South America · Spain · France · United Kingdom · Italy · India · China
Why work with us.Your local presence without opening a company here; a dossier ready on the first attempt; and a single point of contact for the whole process.
You do not need to incorporate a company in El Salvador to register your product. We act as your local representative and procedure responsible party, with address, accredited power of attorney and presence before the SRS when the file requires it.
We review every document against the current SRS requirements and against the criteria the authority actually applies. A complete dossier from the start means a launch date you can plan around.
One person accountable for your account, not a shared inbox. You always know where your procedure stands without chasing us.
What sets us apart
How we work
From diagnosis through post-registration, with a single point of contact behind your dossier.
We classify your product, confirm the registration route before the SRS and give you the exact list of applicable requirements.
We review what you already have and identify what is missing, what must be apostilled or legalized and what must be translated. We adjust artwork and labelling.
We work in partnership with law firms and notaries in El Salvador, and we offer translation of technical and legal documents. You do not have to coordinate three different providers or explain your case three times.
We file the dossier on the SRS platform, pay the fees, follow up and respond to requests for information.
Renewals, variations, import permits, health advertising and expiry control so your registration never lapses through oversight.
Contact
We give you a free initial assessment: the applicable registration route before the SRS and the documents you need to gather. To speed things up, attach what you have at hand: technical data sheet, quantitative and qualitative formula, certificate of free sale and labelling artwork.
