+ 506 6019-1616 info@racostarica.com

Services

Integral solutions for your requirements
Among the multiple requirements that must be met to put a product for human or veterinary use (food, cosmetics, medicines, vitamins) in the market are the Registries requested by the Ministerio de Salud or the Ministerio de Agricultura. These Registries require the submission of multiple documents and a complex processing.

Our company provides the advice to elaborate and obtain the required documents and we also make their submission on the corresponding Ministry. We have professionals in the areas of medicine, pharmacy, veterinary, nutrition, among others, to ensure that the procedures are performed in a technically correct manner and to adequately respond to the observations of the staff of the Ministries.

h

Regulatory Affairs

Intelligence

p

Documentation

Publicity and Marketing

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Registrations and Permits

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Public Tenders

















h

Regulatory Affairs

  • Product evaluation and customer documentation.
  • Analysis of the legal framework that affects the product or service.
  • Advice on the preparation and fulfillment of requirements.
  • Compliance plans and response to potential preventions and rejections.
  • Drug surveillance and Technosurveillance
  • Preparation of strategy and response to sanitary and phytosanitary orders, withholdings and product recalls.
  • Provision of documentation to the regulatory authority.
  • Preparation and maintenance of digital record safe keeping for each client.
  • Monitoring procedures.
  • Institutional Public Relations.
  • Registration in SICOP
  • Incorporation of products in the Caja Costarricense del Seguro Social Catalog

Intelligence

  • Interpretation of technical terminology.
  • Reduction of red tape.
  • Advice on the various options for records or permits for a product or service.
  • Preparation of bureaucratic overviews and estimation of response times for each type of record.
  • Advice for incorporation and sale of products in the CCSS and INS.
  • Market study of products at the CCSS and INS level: Competition, market prices, units sold.
  • Preparation and discussion of the commercial possibilities that each type of registration or permit offers.
  • Advice for the insertion of the product in online sales and wholesale distributors and retail.
  • Analysis of competition and product differentiation.
p

Documentation

  • Technical and scientific design and writing
  • Analysis of technical and scientific product or service requirements.
  • Advice on quantity and quality of information to be provided in each procedure.
  • Compilation and analysis of scientific studies for the presentation of purchases at the government level.
  • Professional preparation of technical documentation.
  • Collection or search for technical and scientific data.
  • Adaptation of information requirements of the country of registration or permission.
  • Design of scientific studies.

Publicity and Marketing

  • Advertising and promotional language
  • Advice on terms and allowed advertising content on labels and media.
  • Adaptation of the original manufacturer’s advertising language to the law of the country of sale.
  • Computer graphic design and advertising for elaboration and adapting packaging and labels.
  • Review of artwork and texts according to the environment in which they are published.
  • Training for distributors and dealers.
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Registrations and Permits

MAIN STEPS IN COSTA RICA AND ABROAD
  • Health Drug Registration.
  • Licensing of Natural Products.
  • Supplements Health Registry.
  • Sanitary Food Registry.
  • Cosmetics Health Registry.
  • Chemical Health Registry.
  • Licensing of tattoo inks.
  • Licensing of Hygiene products.
  • Licensing of Biomedical Equipment.
  • Records and phytosanitary (SPS) permits for import and export.
  • Elaboration of packaging and labeling arts.
  • Monitoring and reporting of drug surveillance and technosurveillance
  • Preparation of advertising and marketing according to regulations.
  • Registration of brands nationally and internationally.
  • Preparation of documentation for exports.
  • Advice for online sales.
  • Registration of veterinary products.
  • Register of agricultural products.
  • Agrochemical Health Registry.
  • Operating Permits (agricultural, industrial, commercial, services and health).
  • Request for certification and authorization of biological samples, radiation, hazardous waste, vaccines, among others.
  • Management and monitoring of post-registration procedures.
  • Filing of complaints.
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Public Tenders

  • Preparation of report of purchases projected by the CCSS according to the product to be traded and the Medical Center that will execute the purchase
  • Daily detection of sales opportunities to the CCSS
  • Daily detection of sales opportunities to the INS
  • Analysis of purchasing requirements published by CCSS / INS
  • Preparation of request for modifications to posters published by CCSS / INS
  • Preparation, presentation and follow-up of objection resources to the poster
  • Preparation, presentation and monitoring of offers for participation in bidding processes published CCSS / INS
  • Compilation of Clinical Studies necessary for offers, objections and revocation before CCSS / INS
  • Preparation, Presentation and follow-up of corrections before CCSS / INS
  • Preparation, presentation and follow-up of appeals and revocation
  • Participation in the process of evaluation of samples in INS
  • Execution of the purchasing process by request in INS
  • Entry and monitoring of offers and resources in SICOP

Contact us

San José, Barrio Los Yoses

Phone Number/Whatsapp:
+506 6019-1616

Schedule:
8:00am-5:00pm Mon - Fri