Regulatory Affairs
and good manufacturing
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Regulatory Affairs
and good manufacturing
Click to See More >>

What is DC Regulatory Services?

DC Regulatory Services is a technical advisory company that operates in the Regulatory Affairs/ CMC and Good Manufacturing Practices areas, in the segments of medicines (including biological ones), medical devices, cosmetics and sanitizing products. The company works in a technical and strategic way for the best solutions to the Brazilian NRA (ANVISA).

With offices in São Paulo and Brasilia, DC Regulatory is able to serve national and international clients through effective and secure communication tools. It has the know-how to achiece satisfactory and conforming results in different regulatory processes.

Complete consultant services on issues related to ANVISA, starting from the appropriate regulatory strategy to achieve good results for the client and for the regulators.

Specialized technical staff with extensive experience in Regulatory Affairs/ CMC and GMP, offering well-targeted consulting services, with a high degree of assertiveness totally aligned to the NRA’s vision.

DC Regulatory Services

Pre-inspection audits are based on Good Manufacturing Practices according to ANVISA standards. DC Regulatory Services helps companies to be prepared and updated with applicable inspection requirements, which may include the participation of our experts during the regulatory agency inspection.

Pre-inspection Audits

We conduct GAP analyses on documents for submission to ANVISA. We elaborate GAP analysis highlighting the deficiencies and their possible corrections to assist in dossier compliance. We prepare dossiers for the registration of generic, branded generic, specific, biological drugs - including the CTD format – and of medical devices. We also work in the post-registration phase, ensuring compliance with all ANVISA reports, including change control and its implications for dossier maintenance.

Regulatory Services

Trademark registration is a process that ensures the identity of your company/product. Our team will assist you from the initial verification through to the publication of your trademark registration, ensuring legal protection across the entire territory. We conduct evaluations in the POCA system and at INPI, ensuring registration in accordance with current regulations.

Brand Registration

Our legal division is composed of a team of entrepreneurial lawyers with extensive experience in the pharmaceutical, life sciences, and healthcare sectors, who have dedicated their careers to companies adhering to the most stringent health standards in accordance with current legislation. DC Regulatory Services is your ideal partner, both in the regularization of companies and products and in the defense of processes related to your registrations. We excel in both advisory and litigation matters, achieving high-performance results within extremely short timeframes.

Legal Advice

Due diligences are important tools in the context of developing new businesses or even in M&A processes. DC Regulatory Services conducts regulatory audits (regulatory due diligence), issuing reports on regulatory risks and providing relevant action plan recommendations.

Due Diligence

We have a strong partnership with an importing/distributing company that holds all the necessary licenses for hosting your company registrations of drug and healthcare products in Brazil.

Hosting Services

DC Regulatory Services utilizes a predictive risk analysis tool for active pharmaceutical ingredients (API’s) or drug products, providing essential support for compliance with RDC 677/2022.

Nitrosamines Risk Assessment

Our company has developed a risk prediction tool for temperature and humidity excursions throughout the pharmaceutical supply chain. With this tool, our clients are able to make informed decisions regarding the need for additional controls during transportation and storage.

RDC 430: Prediction Analysis

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