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.
– Preparation of registration and post-registration dossiers for health products / equipment (correlates);
– Due dilligence, with issuance of regulatory risk reports and suggestions for relevant action plans;
Good Manufacturing Practices
* Deviation treatment
* Change control
* Validation plans
* Annual periodic review for products and systems
* Trend analysis
* Quality Audits of suppliers, including international ones.
– Elaboration of dossiers in CTD format;
– Good Manufacturing Practices (basic and advanced)
– Preparatory to receive international inspection
– Mock-inspections according to ANVISA´s requirements