and good manufacturing
Practices.
and good manufacturing
Practices.
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.
Regulatory Matters
– 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
* Changing control
* Validantion plans
* Periodic review of products and systems
* Trend analysis
* Audits of suppliers, including international suppliers.
Internacionalization
– Elaboration of dossiers in CTD format;
Trainings
– Good Manufacturing Practices (basic and advanced)
– Preparatory to receive international inspection
