In today’s business environment, many companies are seeking more efficient ways to manage their regulatory compliance functions. The growing complexity and constant evolution of regulatory standards demand a more strategic approach to maintaining compliance and ensuring business success. In this context, BPO in RA (Business Process Outsourcing) stands out as an efficient solution.
BPO in RA involves outsourcing regulatory and compliance activities to a specialized external provider. By transferring these functions to experts, companies can focus on their core activities, reduce costs, and ensure that all legal and regulatory requirements are met effectively.
What is BPO in RA?
BPO (Business Process Outsourcing) in Regulatory Affairs (RA) refers to the outsourcing of business processes, and in the regulatory field, it is gaining prominence due to its ability to simplify compliance management. This model allows a company to partially or fully outsource its regulatory functions, which may include:
- Regulatory document management
- Preparation of compliance reports
- Monitoring regulatory changes
- Other activities related to compliance with government and industry standards
In highly regulated sectors, such as medical devices in Brazil, compliance with standards is a fundamental requirement for the entry of new MDs into the market. Additionally, constant regulatory changes make the regulatory process even more challenging.
Benefits of BPO RA for Companies
By adopting the BPO RA model, companies can benefit in several ways, such as:
- Focus on core business: By outsourcing regulatory activities, companies can focus their efforts on their main areas of operation.
- Cost reduction: Hiring external specialists to handle compliance can be more efficient and economical than maintaining a dedicated in-house team.
- Constant updates: BPO RA providers are always up to date with the latest standards and requirements, ensuring that your company remains compliant at all times.
BRISA Advisors’ BPO RA Services
We offer a complete BPO RA solution, which includes:
- Assuming legal and technical responsibility for products before ANVISA (Brazilian Health Regulatory Agency).
- Defining the appropriate regulatory strategy.
- Preparation and submission of technical dossiers for product registration and notification with ANVISA.
- Transfer of product registration ownership.
- Application for Good Manufacturing Practices (GMP) Certificates.
- Acting as the registration holder with regulatory agencies such as ANVISA, INMETRO, and ANATEL.
- Amendments to product registrations.
- Updating Instructions for use (IFU) with ANVISA.
- Distributor qualification and approval.
- Clarification and responses to regulatory inquiries.
- Responsibility for post-market surveillance, including responses to health authorities, monitoring of adverse events, and field actions.
Conclusion
The BPO RA model is a strategic solution for companies that want to optimize compliance management, reduce costs, and ensure they stay up to date with current regulations. By relying on the specialized services of BRISA Advisors, your company can focus on what it does best, while we take care of your regulatory needs.
If you have any questions, contact Brisa Advisors for specialized regulatory support.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
