Regulatory Affairs Consulting & ANVISA Compliance

Suporte profissional para registro na ANVISA, com expertise em submissão de produtos de saúde, cosméticos e farmacêuticos. Professional support for ANVISA registration, specializing in streamlined submissions for health products, cosmetics, and pharmaceuticals.

Regulatory Affairs and

Good Manufacturing and

Distribution Practices

Who We Are

Professional support for ANVISA registration, specializing in streamlined submissions for health products, cosmetics, and pharmaceuticals. Suporte profissional para registro na ANVISA, com expertise em submissão de produtos de saúde, cosméticos e farmacêuticos.

DC Regulatory Services is a technical consultancy company that operates in the Regulatory Affairs/ Chemistry and Manufacturing Controls (CMC) and Good Manufacturing Practices areas, in the segments of drug products (including biologics), medical devices and food supplements. We work in a technical and strategic manner to provide the best solutions to the relevant authorities.

With representatives in Rio de Janeiro, Minas Gerais, and Brasília, DC Regulatory is able to attend national and international clients through effective and secure communication tools. We offer know-how to achieve satisfactory and conforming results in different regulatory processes, during all product regulatory life cycle (registration and post-registration).

We provide complete consultancy services on issues related to ANVISA, starting from defining the appropriate regulatory strategy to achieve satisfactory results for the client and with the regulatory agencies, applying project management in all our process.

We have a specialized and highly experienced technical team capable of offering differentiated consultancy, with a high degree of assertiveness totally aligned to the NRA’s vision.

Guidance on gaining access to the Brazilian market, providing regulatory consulting to meet ANVISA’s stringent health product requirements. Orientação para acesso ao mercado brasileiro, oferecendo consultoria regulatória para atender aos rigorosos requisitos de produtos de saúde da ANVISA.

SERVICES

Expert regulatory compliance consulting for health products with a focus on ANVISA standards and certifications, ensuring full adherence to Brazilian regulations. Consultoria especializada em conformidade regulatória para produtos de saúde, com foco nas normas e certificações da ANVISA para total aderência às regulamentações brasileiras.

Regulatory Services

We perform GAP analysis on documents for submission to ANVISA. We prepare GAP analysis reports, indicating the deficiencies and their possible corrections, supporting the adaptation of the dossier to the Brazilian guidelines. We prepare dossiers for registration, including CTD format, for generic, similar (branded generic), specific products like parenterals or herbal products, and biological drugs, medical devices, and food supplements. We also work in post-registration, ensuring compliance with all ANVISA requirements for maintaining the regulatory life cycle (price approval and updating, commercialization reports, leaflet monitoring, annual change report, and pharmacovigilance) and post-registration variation activities.

Specialized consulting for trademark registration in Brazil, guiding companies through intellectual property protection with security and compliance. Consultoria especializada em registro de marca no Brasil, orientando empresas no processo de proteção de propriedade intelectual com segurança e conformidade.

Brand Registration

O registro de marca é um processo que garante a identidade da empresa / produto. Nossa equipe irá assessorar desde a verificação da viabilidade da marca para uso na ANVISA até a publicação do seu Registro de Marca no INPI, garantido a proteção legal em todo o território.

Due Diligence

Due diligences are important tools in the context of developing new businesses or even in M&A processes. We perform due diligence audits, issuing reports on regulatory risks and providing relevant action plan recommendations for the better decision during the M&A process.

Nitrosamines Risk Assessment

We use a risk analysis tool develop internally to assess the possibility of nitrosamines formation in active pharmaceutical ingredients (API’s) or drug products, providing support for compliance with RDC 677/2022.

Auditorias completas de BPF para garantir a conformidade com as Boas Práticas de Fabricação de acordo com os requisitos da ANVISA. Comprehensive GMP audits to verify and ensure compliance with Good Manufacturing Practices in line with ANVISA requirements.

Audits

We perform vendors qualification and pre-inspection audits (mock inspections), which are based on Good Manufacturing Practices and / or Storage according to current ANVISA guidelines. DC Regulatory Services supports companies to be prepared and updated with applicable inspection requirements, which may include the participation of our experts during the regulatory agency inspection.

Legal Advice

Specialized legal advice for pharmaceutical companies. We offer support in tech-transfer process for Product Development Partnerships (PDP´s) or similar projects and regularization of companies and products, which also includes appealing processes to guarantee dossiers life cycle.

Serviços de hospedagem e manutenção de registros de produtos de saúde, assegurando conformidade contínua com as regulamentações da ANVISA. Hosting and maintenance services for health product registrations, ensuring continuous compliance with ANVISA regulations.

Hosting Services

We have a strong partnership with an importing / distributing company that holds all the necessary licenses for hosting your company registrations of drug and medical devices products in Brazil, ensuring your company the whole dossier management during all the product´s life cycle.

Consultoria especializada em análise de risco conforme RDC 430, auxiliando empresas na gestão de riscos regulatórios. Professional consulting on RDC 430 risk analysis, helping companies navigate regulatory risk management requirements

RDC 430: Risk Analysis

Risk assessment tool developed internally to demonstrate if any additional actions are needed during supply chain (storage and transportation) and / or a risk prediction in case of temperature and humidity excursions.

Serviços de consultoria em estratégia regulatória, incluindo planejamento e implementação de conformidade para produtos de saúde e farmacêuticos. Advisory services on ANVISA regulatory strategy, including compliance planning and implementation for health and pharmaceutical products.

Sindusfarma Quality Award

DC Regulatory was recognized in the 2025 Sindusfarma Quality Award, one of the most prestigious honors in the Brazilian pharmaceutical industry. This achievement highlights the excellence of our work and reinforces the company’s leadership in regulatory solutions for the pharmaceutical sector.

The award reaffirms our ongoing commitment to innovation, technical quality, and trust — pillars that drive us to overcome challenges and consistently deliver the best results to our partners and clients.

More than just recognition, this milestone reflects the dedication of our entire team and the trust we have built over the years within the regulatory sector.

TALK TO THE DC REGULATORY TEAM

DC REGULATORY SERVICES

+55 (21) 99995-2344

contato@dcreg.com.br

O registro de marca é um processo que garante a identidade da empresa / produto. Nossa equipe irá assessorar desde a verificação da viabilidade da marca para uso na ANVISA até a publicação do seu Registro de Marca no INPI, garantido a proteção legal em todo o território.

Due diligences are important tools in the context of developing new businesses or even in M&A processes. We perform due diligence audits, issuing reports on regulatory risks and providing relevant action plan recommendations for the better decision during the M&A process.

We use a risk analysis tool develop internally to assess the possibility of nitrosamines formation in active pharmaceutical ingredients (API’s) or drug products, providing support for compliance with RDC 677/2022.

Specialized legal advice for pharmaceutical companies. We offer support in tech-transfer process for Product Development Partnerships (PDP´s) or similar projects and regularization of companies and products, which also includes appealing processes to guarantee dossiers life cycle.

We have a strong partnership with an importing / distributing company that holds all the necessary licenses for hosting your company registrations of drug and medical devices products in Brazil, ensuring your company the whole dossier management during all the product´s life cycle.

Risk assessment tool developed internally to demonstrate if any additional actions are needed during supply chain (storage and transportation) and / or a risk prediction in case of temperature and humidity excursions.

DC REGULATORY SERVICES

+55 (21) 99995-2344

contato@dcreg.com.br

O registro de marca é um processo que garante a identidade da empresa / produto. Nossa equipe irá assessorar desde a verificação da viabilidade da marca para uso na ANVISA até a publicação do seu Registro de Marca no INPI, garantido a proteção legal em todo o território.

Due diligences are important tools in the context of developing new businesses or even in M&A processes. We perform due diligence audits, issuing reports on regulatory risks and providing relevant action plan recommendations for the better decision during the M&A process.

We use a risk analysis tool develop internally to assess the possibility of nitrosamines formation in active pharmaceutical ingredients (API’s) or drug products, providing support for compliance with RDC 677/2022. ​

Specialized legal advice for pharmaceutical companies. We offer support in tech-transfer process for Product Development Partnerships (PDP´s) or similar projects and regularization of companies and products, which also includes appealing processes to guarantee dossiers life cycle.

We have a strong partnership with an importing / distributing company that holds all the necessary licenses for hosting your company registrations of drug and medical devices products in Brazil, ensuring your company the whole dossier management during all the product´s life cycle.

Risk assessment tool developed internally to demonstrate if any additional actions are needed during supply chain (storage and transportation) and / or a risk prediction in case of temperature and humidity excursions.

We use a risk analysis tool develop internally to assess the possibility of nitrosamines formation in active pharmaceutical ingredients (API’s) or drug products, providing support for compliance with RDC 677/2022.