Pharmaceutical Regulatory Affairs in Brazil

Name: Pharmaceutical Regulatory Affairs in Brazil
Address: Units 444-451, Tower B2, 4th Floor Spaze-I-Tech Park, Sector 49,, Gurugram, Haryana, Haryana, 122018
Telephone: +91 9650691491

Listing ID: 90952 2026-01-23

Categories Health Care Consultants

Units 444-451, Tower B2, 4th Floor Spaze-I-Tech Park, Sector 49, , Gurugram, Haryana - 122018

Phone: +91 9650691491
Website: https://www.ddregpharma.com/global-reach/regulatory-services-in-brazil/pharmaceutical-products
Email: [email protected]

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Business description

The page outlines how the company assists global and local pharmaceutical firms in navigating the regulatory requirements set by ANVISA (Agência Nacional de Vigilância Sanitária). Key services described include:

End-to-End Drug Registration: Support for new drugs, generics, biologics, and "similar" products.

Local Representation: Providing Brazilian Registration Holder (BRH) support for foreign companies.

Dossier Management: Preparation and submission of registration dossiers (CTD/eCTD formats) and gap analysis.

Lifecycle Management: Handling post-approval needs such as renewals, variations, and compliance monitoring.

Strategic Consulting: Guidance on priority review pathways, GMP certification support, and regulatory intelligence.

Essentially, the page positions DDReg as a specialized consultancy that helps companies manage the technical and legal complexities of entering and maintaining a presence in the Brazilian pharmaceutical market.

Business hours

Monday 09:00 – 17:00
Tuesday 09:00 – 17:00
Wednesday 09:00 – 17:00
Thursday 09:00 – 17:00
Friday 09:00 – 17:00
Saturday Closed
Sunday Closed

Frequently asked questions

Where is Pharmaceutical Regulatory Affairs in Brazil located?

Pharmaceutical Regulatory Affairs in Brazil is located at Units 444-451, Tower B2, 4th Floor Spaze-I-Tech Park, Sector 49, , Gurugram, Haryana - 122018.

How can customers contact Pharmaceutical Regulatory Affairs in Brazil?

Customers can contact Pharmaceutical Regulatory Affairs in Brazil by phone at +91 9650691491.

Does Pharmaceutical Regulatory Affairs in Brazil have an official website?

Yes, the official website of Pharmaceutical Regulatory Affairs in Brazil is https://www.ddregpharma.com/global-reach/regulatory-services-in-brazil/pharmaceutical-products.

Does Pharmaceutical Regulatory Affairs in Brazil provide email support?

Yes, customers can contact Pharmaceutical Regulatory Affairs in Brazil via email at [email protected].

Is Pharmaceutical Regulatory Affairs in Brazil active on social media?

Yes, Pharmaceutical Regulatory Affairs in Brazil is active on Facebook, Instagram, LinkedIn, YouTube, X.

What are the business hours of Pharmaceutical Regulatory Affairs in Brazil?

Monday 09:00 - 17:00, Tuesday 09:00 - 17:00, Wednesday 09:00 - 17:00, Thursday 09:00 - 17:00, Friday 09:00 - 17:00, Saturday Closed, Sunday Closed.

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