The term “BPO” refers to “Business Process Outsourcing,” and in the context of regulatory compliance services within an organization, there is a growing trend of Regulatory BPO services. This service model involves outsourcing some or all of the regulatory and compliance functions of a company to an external service provider. These services can include regulatory document management, compliance reporting, monitoring evolving regulations, and other activities related to compliance with government standards and regulations.
Outsourcing these activities can allow companies to focus on their core competencies and reduce costs, as regulatory compliance experts can handle specific tasks related to regulations, standards, and industry-specific requirements. Regulatory BPO is common in highly regulated industries such as pharmaceuticals and medical devices, where regulatory compliance is critical to business success and can be complex and constantly evolving.
While they have similarities, BPO and outsourcing are not the same thing. Outsourcing refers to delegating a specific task to another company. On the other hand, BPO goes beyond delegating one or two tasks and involves outsourcing entire business processes. For example, if a company wants to create a new logo for its business but doesn’t want to hire a designer, it can outsource the logo creation to an agency or a freelance professional. This is outsourcing. BPO, on the other hand, would involve hiring another company to handle all aspects of visual communication and graphic design.
This is the essential difference between the two. Additionally, BPO often comes with a higher cost than outsourcing since it encompasses a broader range of services. Also for this reason, BPO providers typically offer more innovative solutions with a higher degree of technological sophistication.
With BRISA’s BPO in RA, your company gains access to all possible regulatory services, including:
- Assuming legal and technical responsibility for products before ANVISA (the Brazilian Health Regulatory Agency).
- Defining regulatory strategy.
- Preparing and submitting technical dossiers for product registration and notification to ANVISA.
- Transferring ownership of registrations.
- Requesting Good Manufacturing Practice (BPF) certificates.
- Acting as the product registration holder with Regulatory Agencies such as ANVISA, INMETRO, and ANATEL.
- Facilitating changes in product registrations.
- Updating Instructions for Use (IFU) with ANVISA.
- Qualifying and approving distributors.
- Providing clarifications for inquiries.
- Being responsible for post-market surveillance of products, including responding to health authorities, adverse events, alerts, and field actions.
* Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br
