For a company to work with products regulated by ANVISA, it is necessary, firstly, that the company gets the sanitary Surveillance Authorizations to carry out activities related to these products at the Municipal, State and National levels. To do so, the company must comply with the technical and administrative requirements contained in the current legislation.

Lycens – Regulatory Affairs is able to assist its partners in obtaining the Operating License issued by the local Sanitary Surveillance and the Company Operation Authorization (AFE) granted by ANVISA for all activities to be performed.

Obtaining the Certificate of Good Manufacturing Practices (GMP/CBPF) and Good Storage and Distribution Practices (CBPAD) becomes of great relevance in a market that requires increasing quality for the products. 

Good Manufacturing (GMP) and Distribution and Storage (CBPAD) Practices consist of a set of actions and procedures the companies must adopt within the product life cycle in order to guarantee the quality and the conformity of the products through a Quality Management System.

The Certification of Good Manufacturing Practices is  mandatory for some products in areas such as medical devices and medicines, adding to the requirements already necessary for companies to carry out their activities. In other areas, however, Certification is not mandatory, but it is a differential in the current competitive market.

Lycens – Regulatory Affairs is able to help its partners to obtain these Certificates (GMP/CBPAD) from ANVISA and verify the implementation of its Quality Management System.

In order to have cosmetics, medicines, cleaning products, medical devices, food products and tobacco products in the marketed, it is necessary to register it in the National Agency of Sanitary Surveillance – ANVISA.

Lycens is able to work with its partners during all stages of product regularization: manufacturing, importation, distribution and transportation in an agile and appropriate manner.

Lycens works with the following services:

Medicines: Registration, post-registration alteration, simplified notification of new, generic, biological and specific drugs;

Medical Devices: Registration and post-registration alteration of materials, equipment and devices for in vitro diagnostics;

Cosmetics: Notification, registration and post registration alteration of cosmetics, hygiene products and perfumes;

Sanitizing products: Notification, registration and post registration alteration of cleaning products;

Food products: Registration of novel food product, with functional or health claims and communication of commencement of importation and manufacture of food;

Tobacco products: registration of companies and tobacco products;

Due to the range of options for product regularization at ANVISA, Lycens – Regulatory Affairs acts by classifying products, analyzing its physicochemical characteristics and issuing technical-scientific reports regarding the viability of its registration at ANVISA.

Technical-scientific Report: Elaboration of Technical-scientific Report to demonstrante efficacy and safety for drug registration in Brazil.

The Technical-scientific Report is made using data published in indexed journals present in several electronic scientific bases including PUBMED, MEDLINE, SCOPUS, COCHARNE and SciELO .

We elaborate an initial report with the title of the articles selected considering the chemical entity or active pharmaceutical ingredient (API), pharmaceutical form, posology and route of administration of the product to be registered; We analyzed the level of scientific evidence of the publications and evaluate the feasibility of proving efficacy and safety through scientific literature. Finally, we prepare a complete technical-scientific report for the purpose of proving the efficacy and safety of the product of interest.

Regulatory framework: Evaluate the physical chemical characteristics of the product and define the classification of classification of its pharmaceutical product , medical device or food in which the product will be framed.

Lycens – Regulatory Affairs evaluates the physicochemical characteristics of the product, its production process, pharmacotechnical development, quality, safety and efficacy in order to define the classification of its pharmaceutical product at ANVISA. A pharmaceutical product can be considered as generic, similar, biological, new, innovative, specific, herbal, among others. That way, you need to know what kind of class your product belongs to in order to register it correctly in ANVISA. We prepared a framework report of the drug presenting the entire legal and normative basis for its classification.

Scientific Papers: Write scientific papers (English / Portuguese) after providing research data.

Lycens Regulatory Affairs acts by writing scientific articles (English / Portuguese) based on previous research and data provided. We write the articles; review of articles already written; analyze the research carried out by the company; suggest the best journals for publications and analyze the quality of journals (Qualis rate).

Veterinary products, whether chemical, biological, biotechnological, for the prevention, treatment or cure of disease in animals, require prior registration at the Ministry of Livestock and Supply (MAPA).

In order for you to register the veterinary medicine in MAPA, it is first necessary to regularize the establishment at MAPA. See how Lycens Regulatory Affairs can assist you in regularizing your company and in registering veterinary products on MAPA.

Establishment Registration – MAPA: companies that act as Manufacturer (including packers, fractionators, labelers and packagers), stores, distributors, importers, exporters and laboratories of quality control of veterinary products for themselves or for third parties must, be registered at MAPA. Lycens Regulatory Affairs acts by advising you to obtain the sanitary license and its renew at the Ministry.

Registration of Veterinary Products and Biological Products: In order to have Brazilian or imported veterinary products marketed in the Brazil, it is necessary to register at MAPA. Lycens Regulatory Affairs assists you in the veterinary product registration and renew.

The use of remediators is a viable option in actions to recover contaminated ecosystems, and in the treatment of waste and effluents. However, due to their peculiarities or inadequate use, the remediators can cause imbalance to the exposed ecosystem and result in damages to the environment. In this context, the previous registration at IBAMA is mandatory. Learn how Lycens can assist you in the remediators registration and renew.   

Physical chemical remediator: remedial agent that presents as an active ingredient chemical or oxidizing substance, surfactant or dispersant, or polymers, enzymes, among others, capable of degrading, adsorbing or absorbing compounds and contaminants.

Bioremediator: a remedial agent that has microorganisms capable of reproducing and biochemically degrading compounds and contaminants as an active ingredient.

– Process Submission Express

Knowing that ANVISA and MAPA requires the physical protocol of most of the processes, and aiming for security reliability and agility in the demands of our customers, Lycens – Regulatory Affairs offers the Process Submission Express service, which consists of:
• Receive the process to submit to ANVISA and MAPA;
• Check the documents and verify the suitability to the requirements demanded by the Agency;
• Submit the process at ANVISA’s and MAPA´s headquarters daily.
• Promptly send the proof of protocol by e-mail and the original receipt via the Post Office.

With the Lycens Process Submission Express service the company saves time and is reassured that the process will be submitted to ANVISA and MAPA promptly and adequately.

– Acquisition of regulated companies

With Lycens you can acquire companies that are properly regulated in the Sanitary Authorities. Because of that, products can be registered promptly once the time and the necessary resource for the regularization of a new company is reduced.

– Trademark and Patents

To have exclusivity about the name of a product, or a logo that identifies it, it is necessary to register the brand. The registration must be done in a specific federal agency, the National Institute of Industrial Property – INPI.
In the case of an invention of new technology for product or process, it is recommended to seek the right to the patent.
Check with Lycens about trademark and patent registration!