MISCELLANEOUS

What is Advisory and Consulting for ANVISA?

The Advisory and Consulting for ANVISA is realized by a company, specialized in the field, which takes care of the entire regularization process of products and companies. From the initial stage, which is the Operating License and Authorization of Operation Company, to the Registration of Products and other services.

When regularizing your company or product, you will come across several regulatory steps, this can occur because of the numerous secretariats and coordinations of the brazilian National Health Surveillance Agency (ANVISA) directly or indirectly linked to it.

Currently there are several normative instructions, rules and steps for each activity that must be followed together with the competent agency, and for this it’s necessary to hire a good advisory and consulting company.

What is the advice and consulting for ANVISA?

Thus, we understand that for each activity that will be carried out there are numerous rules that must be accepted in order for the company to perform the activity mentioned. Therefore, the goal of hiring an Advisory and Consulting for ANVISA is to know that all regulatory planning will be done exclusively for you and your company.

Our job is to facilitate the entire regularization process that your company or product may need. So, if bureaucracy isn't your thing, contact Stone Okamont, we do all the work for you from start to finish. No rework and unnecessary expenses. All this using our Zero Bureaucracy method.

We are specialists in Advisory and Consulting for ANVISA. We are in the Regulatory Services area planning all regulatory procedures according to the client's interests. Stone Okamont’s exclusivity and expertise make it the ideal company to regulate and register healthcare products and companies quickly, accurately and simply.

Where to do the Advisory and Consulting for ANVISA?

Stone Okamont is a reference Advisory and Consulting for ANVISA! We are a responsible company and guarantee the best so the customer always wins. We work together with companies that carry out activities involving products under the jurisdiction of the brazilian Sanitary Surveillance such as: Medicines and Pharmaceutical Inputs, Cosmetics, Health Products (Related), Sanitizing and Food.

Among the regulatory activities offered by Stone Okamont are:

• Technical Assessment Report (LTA);
• Implantation of the System of Quality;
• Local Operating License;
• Company Operation Authorization (AFE);
• Alteration, Expansion or Reduction of activities in the AFE;
• Certification of Good Manufacturing Practices (CBPF);
• Product Regulations;
• Regulatory Audit Services, among others.

For international company we also provide Assessorial and Consultoria for ANVISA, services such as: inspection monitoring, Auditing, Holder Services (International Product Hosting) and harmonization and preparation of the Quality System along ANVISA’s criteria.

How can we help?

The regulatory affairs sector is responsible for the regularization of products and establishments. We operate in a personalized way, using tools and technicians specialized in the area of operation of each company, optimizing its registration process.

We make the entire process more economical, and fast, with customized and simplified service, using the Zero Bureaucracy method, in order to establish the regulatory strategy for the success and competitive advantage of the company.

See below more of our Regulatory Services.