DDReg Pharma

Regulatory Services

Our regulatory services can help devise tailored strategies, provide technical processes and on-going support in Due-Diligence, Gap Analysis, New Product Authorizations and more.

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.

Please write to us if you have any query
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...

Regulatory Due Diligence

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

Gap Analysis and Remediation

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

New Product Authorizations

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

Post Approval Life Cycle Management

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

CMC Advisory

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

API/DMF

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

Send us a Message