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

Regulatory Affairs

– Elaboration of registration dossiers and post-registration of generic, similar, specific and biological drugs;
– 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

Evaluation of quality systems in the areas of medication, including biologicals, health (and related), cosmetics and sanitizing products, including:
* Deviation treatment
* Change control
* Validation plans
* Annual periodic review for products and systems
* Trend analysis
* Quality Audits of suppliers, including international ones.

Internacionalization

– Management and support to internationalization programs, with revision of quality systems and subsystems according to different regulatory requirements (FDA, EMA and WHO)
– Elaboration of dossiers in CTD format;

Trainings

– Regulatory Affairs
– Good Manufacturing Practices (basic and advanced)
– Preparatory to receive international inspection
– Mock-inspections according to ANVISA´s requirements

Talk to DC Regulatory Services

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