Write to us at:
The sanitary registration of medicines in Peru is a fundamental requirement for pharmaceutical companies and manufacturers seeking to enter and market their products in the Peruvian market.
In IzzoMed We provide regulatory affairs services for companies and manufacturers that need to manage the drug registration in Peru, from the initial product evaluation and documentation review to the preparation and management of the corresponding procedure before DIGEMID.
Our work begins with identifying the applicable requirements for the drug and evaluating the available documentation. This allows us to establish an appropriate regulatory strategy for each product and project.
We work with national and international manufacturers, including pharmaceutical companies seeking to introduce their medicines into the Peruvian market and need regulatory support and local representation.
In IzzoMed We provide regulatory affairs services for companies and manufacturers that need to manage the drug registration in Peru, from the initial product evaluation and documentation review to the preparation and management of the corresponding procedure before DIGEMID.
Our work begins with identifying the applicable requirements for the drug and evaluating the available documentation. This allows us to establish an appropriate regulatory strategy for each product and project.
We work with national and international manufacturers, including pharmaceutical companies seeking to introduce their medicines into the Peruvian market and need regulatory support and local representation.
Services for the sanitary registration of medicines in Peru
Each drug and each manufacturer has different regulatory requirements. That's why our service is tailored to the product's characteristics, its documentation, and the project's objectives.
Regulatory assessment
We analyze the characteristics of the drug, its manufacturer, and the available documentation to identify the applicable regulatory requirements.
This assessment allows us to understand the project's conditions before starting a procedure and to detect possible documentary or regulatory gaps.
This assessment allows us to understand the project's conditions before starting a procedure and to detect possible documentary or regulatory gaps.
Documentation review
We reviewed the available technical and administrative information to identify missing documents, inconsistencies, or aspects that need to be supplemented before moving forward.
The initial review allows for organizing the documentation and establishing a clearer work plan for the project.
The initial review allows for organizing the documentation and establishing a clearer work plan for the project.
Regulatory strategy
Together with the client, we define the most appropriate regulatory approach for the product.
The strategy takes into account the characteristics of the drug, the available information, and the applicable requirements in Peru, seeking to ensure that the project progresses in an orderly manner and with adequate planning.
The strategy takes into account the characteristics of the drug, the available information, and the applicable requirements in Peru, seeking to ensure that the project progresses in an orderly manner and with adequate planning.
Preparation and management of the file
We provide support in the preparation and organization of the documentation necessary to develop the corresponding procedure before the health authority.
Our goal is to facilitate the management of the file and ensure that the required information is properly organized before submission.
Our goal is to facilitate the management of the file and ensure that the required information is properly organized before submission.
Local representation and support
Foreign manufacturers wishing to enter the Peruvian market may need to have a local structure in place to carry out certain regulatory activities.
IzzoMed provides Representation and regulatory support in Peru for international companies seeking to develop their pharmaceutical projects in the country.
IzzoMed provides Representation and regulatory support in Peru for international companies seeking to develop their pharmaceutical projects in the country.
Monitoring of the regulatory procedure
We accompany the project during the different stages of the procedure, carrying out the corresponding follow-up and coordinating with the client the necessary actions when additional information or documentation is required.
Our work aims to maintain clear communication throughout the project development.
Our work aims to maintain clear communication throughout the project development.
Sanitary registration of medicines for international manufacturers
For a foreign manufacturer, introducing a drug to the Peruvian market involves understanding local requirements and having a structure that allows for the proper management of its regulatory activities.
In At IzzoMed we work with international manufacturers and pharmaceutical companies who are seeking to introduce their medicines into Peru.
We can participate from the earliest stages of the project, starting with product evaluation and review of available documentation, through regulatory procedure management and local representation.
Our approach aims to help manufacturers understand what they need to advance in the Peruvian market before committing resources to a procedure.
In At IzzoMed we work with international manufacturers and pharmaceutical companies who are seeking to introduce their medicines into Peru.
We can participate from the earliest stages of the project, starting with product evaluation and review of available documentation, through regulatory procedure management and local representation.
Our approach aims to help manufacturers understand what they need to advance in the Peruvian market before committing resources to a procedure.
Our approach to pharmaceutical projects
Each project has different characteristics. That's why, before defining the service, we evaluate the product, the manufacturer, and the available documentation.
1. We evaluate
We analyzed the drug, its manufacturer, and the available information to understand the characteristics of the project.
2. We identify
We determine the applicable regulatory requirements and the main documentary needs of the product.
3. We plan
We defined a strategy and the necessary steps to develop the regulatory project.
4. We manage
We assist in the preparation and management of the corresponding procedure before the health authority.
5. We accompany
We provide support during the process and, where appropriate, after obtaining the health registration.
What documentation is needed to register a medicine in Peru?
The required documentation depends on the characteristics of the drug, the manufacturer, and the applicable procedure.
Therefore, we recommend performing a prior regulatory assessment before starting the process.
The information that may be needed to evaluate a project includes documentation related to:
Therefore, we recommend performing a prior regulatory assessment before starting the process.
The information that may be needed to evaluate a project includes documentation related to:
The documentation must be evaluated individually to determine which requirements apply to each medication.
Why conduct a regulatory assessment before registration?
Initiating a procedure without prior knowledge of the product's regulatory requirements can lead to delays, requests for additional information, or the need to supplement documentation.
An initial regulatory assessment allows:
An initial regulatory assessment allows:
At IzzoMed we believe that good regulatory planning begins before submitting the file.
Regulatory issues and access to the Peruvian market
Sanitary registration is an important part of the process of bringing a drug to market, but a pharmaceutical project may involve other subsequent needs.
Therefore, our work can be complemented with services related to the import, storage, distribution and marketing of health products, according to the characteristics and needs of each project.
This vision allows our clients to comprehensively assess their regulatory and operational needs.
Therefore, our work can be complemented with services related to the import, storage, distribution and marketing of health products, according to the characteristics and needs of each project.
This vision allows our clients to comprehensively assess their regulatory and operational needs.
Do you work with foreign manufacturers?
We work with international manufacturers and pharmaceutical companies seeking to introduce their medicines to the Peruvian market.
Our support may include initial regulatory assessment, document review, regulatory strategy, procedure management, and local representation, depending on the needs of each project.
Our support may include initial regulatory assessment, document review, regulatory strategy, procedure management, and local representation, depending on the needs of each project.
Do you want to register your medication in Peru?
If you are a pharmaceutical manufacturer or a company seeking to introduce a drug to the Peruvian market, We can evaluate your project and help you identify the regulatory requirements and services you may need.
Tell us about your product, manufacturer, and project. We'll evaluate the available information and define the next steps.
Tell us about your product, manufacturer, and project. We'll evaluate the available information and define the next steps.