home ingles – base – apenas para edicao

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 and Good Manufacturing Practices areas, in the segments of medication (including biological ones), health products (correlates), cosmetics and sanitizing. The company works in a technical and strategic way for the best solutions to the competent bodies.

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 obtain satisfactory and conforming results in regulatory processes.

Complete advice on issues related to Sanitary Surveillance. Guidance from the definition of regulatory strategies to obtaining the satisfactory result from regulatory agencies.

Specialized technical staff with extensive experience in Sanitary Surveillance that offers differentiated consulting, with a high degree of assertiveness and in line with the regulatory body’s vision.

DC Regulatory Services

Regulatory Matters

– 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
* Changing control
* Validantion plans
* Periodic review of products and systems
* Trend analysis
* Audits of suppliers, including international suppliers.

Internacionalization

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

Trainings

– Regulatory Matters
– Good Manufacturing Practices (basic and advanced)
– Preparatory to receive international inspection

Talk to DC Regulatory Services

    Fale Conosco