In the development and delivery of regulatory solutions, technical excellence is inseparable from the principles that guide an organization’s conduct. At Vita, the quality of the services we provide is a direct reflection of the core values that guide every assessment, recommendation, and interaction with our clients and partners.

Our journey is built upon a set of fundamental pillars, our principles and values: 

• Fairness:thoughtful actions guided by ethics and mutual respect.
• Transparency: building and maintaining trust among all stakeholders through clear, objective, and open communication.
• Collaboration: fostering relationships based on empathy and a thorough understanding of both internal and external perspectives, enabling us to deliver comprehensive solutions to our clients.
• Trust: establishing internal connections founded on honesty and integrity, with confidence in the intentions and actions of others.
• Expertise: continuously enhancing technical capabilities through ongoing learning, staying abreast of emerging trends, sharing knowledge, and delivering added value through our services. 

The integration of these principles ensures regulatory support that not only meets the requirements of health authorities, promoting legal certainty and operational efficiency, but also drives our clients’ success and strengthens long-lasting partnerships.

Services that we provide

The breadth of a regulatory strategy is only as strong as the portfolio of capabilities behind it. Here is a closer look at what Vita Pharma Consulting delivers across Brazil, Portugal, Latin America, and Europe. Regulatory affairs is not a single discipline. It is the intersection of scientific rigor, legal intelligence, and operational precision — applied across different jurisdictions, product categories, and stages of a product’s lifecycle. Vita’s service portfolio was built around that reality. 

Strategy & Regulatory Intelligence 

From the initial assessment of a target market to the definition of submission pathways, Vita supports companies in mapping regulatory requirements, evaluating risks, and building technically sound strategies for new marketing authorizations and post-approval changes. This service is available across Brazil, Portugal, and Latin America. 

Dossier Preparation & Submission 

Vita instructs, converts, or develops full dossiers in CTD and e-CTD formats, including internal training. Vita counts with expertise for submissions to ANVISA, INFARMED, and other Latin American health authorities. Support for Certificate of Suitability (CEP) submissions to EDQM is also available for European operations. 

Lifecycle Management & Compliance 

Vita provides ongoing support to lifecycle management, regulatory compliance audits and advises on responses to regulatory requests from health authorities. 

Regulatory Representation 

For foreign companies operating in Brazil or Portugal, Vita acts as the local regulatory representative before the local health authorities, ANVISA and INFARMED. In Brazil, Vita may act as the representative for CADIFA and GMP Certification. 

Pharmacovigilance (Portugal) 

Vita manages the full outsourcing of pharmacovigilance activities in compliance with INFARMED requirements. 

Market Access (Portugal) 

Beyond the marketing authorization, Vita supports the economic evaluation, pricing definition, and reimbursement applications for medicinal products approved in Portugal. 

Due Diligence & Technical Audits 

Vita conducts technical audits of product dossiers to identify regulatory gaps and compliance risks, as well as definition of corrective actions suggestions. 

Technical-Scientific Translation 

Translation of regulatory dossiers and supporting technical documentation, ensuring terminological precision across Portuguese, English, and Spanish. 

New Business Development 

Vita actively supports business prospecting and the approximation between pharmaceutical and API companies across Latin America and Europe. 

Each engagement is shaped by the specific regulatory environment of the target market and the technical characteristics of the product. No template. No one-size-fits-all approach. 

Project Management

Within Vita’s structure, each project follows a standardized journey to transform strategy into results. Regardless of the type of service, some steps are essential to ensure predictability, alignment, and excellence in execution.

Project Initiation

Upon proposal approval, Senior Management assembles the project team based on the client’s specific needs and each consultant’s area of expertise.

This team consists of a leader and execution consultants, and is responsible for organizing the information available for project execution.

Planning

Once the client’s information and documentation are received, the team maps this information. The project lead defines the necessary steps for execution and the corresponding responsibilities, creating the project timeline. Based on this, the client is informed of the formal start of the project, including scope alignment, timelines, and expectations with all parties involved.

Execution

This is our core strength and excellence: the planned activities are carried out with continuous monitoring and a consistent focus on value delivery — the stage where the defined methodology translates into concrete results for the client.

Closure

The planned and agreed results are delivered at this stage. Depending on the client’s needs and the scope of the approved proposal, post-delivery support may include a follow-up period for questions and a formal results presentation meeting.

Internally, the team reviews performance indicators and documents lessons learned before formally closing the project — a practice aligned with structured project management frameworks, which treat closure as an essential phase for institutional learning and continuous improvement. Beyond deadline control, this approach promotes governance, cross-team integration, and knowledge management, transforming each project into a more predictable, efficient, and repeatable process.

Quality Assurance

In technical regulatory consulting, attention tends to focus on technical deliverables, regulatory compliance, and project timelines. Yet there is an underlying function that sustains the quality of every single output: Quality Assurance. 

More than a support area, Quality Assurance is responsible for establishing the foundations that allow processes to be executed in a standardized, consistent, and reliable manner — aligned with best practices. 

In a technical regulatory consulting environment, every project represents a commitment to conformance, information security, and client trust. Meeting those commitments requires a well-structured QMS: documented processes, clearly defined responsibilities, and activities conducted uniformly regardless of the complexity or scope of the project involved. 

The quality function also needs to be embedded in organizational culture — promoting process-oriented management, a focus on client needs, data-driven decision-making, and a continuous drive for improvement. These are, in fact, the central principles of ISO 9001, standard which orients Vita’s Quality Management System (QMS). 

Knowledge management is another essential pillar. Every challenge faced in a technical regulatory project generates concrete learning. Capturing those learnings, sharing best practices, and converting individual knowledge into organizational knowledge strengthens the company and expands its capacity to deliver. At Vita, this happens through structured records and periodic reviews of our processes. 

Risk management, information traceability, and project governance also play a decisive role. Anticipating risks, ensuring control over information throughout the entire project lifecycle, and establishing clear mechanisms for monitoring and decision-making all contribute to increasing delivery reliability and reinforcing the trust clients place in their consulting partner. 

Building a quality culture does not happen overnight. It is a continuous process that demands commitment, discipline, and leadership. But the results are clear: greater efficiency, reduced rework, more confidence for partners, clients, and employees, more predictable deliveries, and a significantly higher capacity to generate value. 

In an increasingly complex and dynamic regulatory environment, Quality Assurance is not merely a differentiator — it is a strategic requirement for organizations that pursue excellence, credibility, and sustainable growth. At Vita, this is our daily commitment.