RAF Consulting

ESP/ENG

+52 55 5683-5496 | +52 55 5920-6339

About Us

Founded on 2011, Rafconsulting® is a team of professionals with great experience in regulatory affairs, specialized in regulatory strategy and intelligence and in the regulatory compliance of healthcare products (medicines and medical devices), including everything related to registration and pharmacovigilance.

Our clients are national and foreign companies that want to market their products in Mexico.

Our competitive advantage is an authentic understanding of the needs of commercial areas and the dominion of the Mexican regulation. Our bilingual team is up-to-date, qualified and trained to deal with the modern challenges and to overcome our clients’ expectations, on time and form, making simple for them the most complex.

Since we provide a comprehensive service, we can also help you with technical and certified translations of the required documents, as well as certified copies, right session contracts, etc., so you won’t have to worry about anything, including submission and follow-up with Cofepris until resolutions are achieved.

Since 2011, we are a company with great experience and professionalism in every service we provide. We are committed to support the healthcare industry and any other area that requires regulatory and pharmacovigilance services.

We have a deep understanding of regulations and regulatory procedures, which allows us to provide the most adequate solution, minimizing costs, optimizing time, and achieving marketing authorization (registration) of a wide range of products.

We also have great experience in explaining to manufacturers (information providers) the type of required documents for the registration, as well as Cofepris’ requirements for authorization. We have deep knowledge about regulations in other countries, so we will get along with your dossier providers.

We specialize in regulatory affairs of drugs and medical devices of foreign manufacture. We collaborate with companies from almost every country: Europe, America, and Asia.

We can help you with a single project or become your Regulatory Affairs Department and solve everything for you.

Our Team

Every member of our team is a healthcare professional with great experience in different areas of regulatory affairs and/ or pharmacovigilance.

Our team is bilingual (English and Spanish).

The overall experience of the team is of more than 40 years, in which we have achieved a great amount of sanitary registrations and marketing authorizations.

We have a continuous training program that allows us to be at the forefront and a quality system that provides consistency to our services.

Competitive advantages

Complete understanding of commercial areas’ needs

Comprehensive, flexible, customized services of great quality and on time.

We exercise policies of strict confidentiality, professional ethics, and no-interest conflict, which have passed the strictest Due Diligences with multinational companies.

Our team is formed of bilingual, well-experienced healthcare professionals with continuous training and qualification, which allow us to always be at the forefront.

Commitment of continuous improvement, as we are constantly updated in Cofepris’ (Federal Commission for Protection Against Sanitary Risks) regulations and new criteria.

We have an auditable and documented Quality System.

We own servers for information storage and protection, backed up by on-edge technology and a high information security level.

We have a broad commercial-partner-and-contacts network to provide a comprehensive service and be able to solve most of our clients’ requirements.

Close and regular communication with Regulatory Health Authorities, Colleges, Chambers, and Associations. Beyond being up to date, we are actively involved in regulation improvement.

Our clients