At DDReg we provide end-to-end Regulatory Affairs Services

As regulations become more stringent, it is important to stay updated with these changes to ensure product approval. Partnering with subject matter expertise that bring experience and knowledge for regulated and emerging markets that drive regulatory activities with high-end technology ensures that pharmaceutical products reach the market in a timely manner. This minimizes risk to business and greater return of investments.

DDReg brings decades of regulatory experience of over 130 countries and has worked with global authorities worldwide for regulated and emerging markets. Our deep knowledgebase expertise provides regulatory services that includes developing tailored regulatory strategies for global filing of products, gap analysis & remediation, due diligence, new product marketing authorizations for drug substance and drug products, product lifecycle management including variations and change control planning & management, CMC services, API & DMF services and more.

Our global eCTD regulatory submission management and publishing services incorporate high-end automation tools and best practices to deliver solutions for submission management and publishing challenges. This includes legacy document conversions, SPL publishing, and e-Conversion for submission to agencies such as the US FDA, EMA, UK MHRA, Saudi FDA, TGA Australia. DDReg is reputed by its customers for delivering high-quality regulatory results to ensure that our customers’ products obtain rapid market access with 100% success rate.

Our Regulatory Consulting portfolio covers:

Regulatory Strategies / Expert Views

Regulations pertaining to pharmaceutical products are continuously changing...

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New Product Authorizations

Pharmaceuticals and other medicinal products need to be prior authorized by...

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Gap Analysis and Remediation

A gap analysis is a regulatory review process that identifies data gaps in the technical...

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Regulatory Due Diligence

Regulatory issues arise unexpectedly and can create significant strain on a company’s...

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DDReg provides expert consulting and efficient services for quality Drug Substance...

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CMC Advisory

When it comes to regulatory strategies, CMC documentation play a crucial role in developing...

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Post Approval Life Cycle Management

Managing the post-approval life cycle of a product is an essential component to sustaining...

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Regulatory Certification

Regulatory Certification

Administrative documents are an integral component of regulatory submissions and constitute key certifications...

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