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.

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...

Regulatory In-house Resource Services

Data confidentiality, driven by IPR, is often the rate limiter for many pharma organizations to go for regulatory ...

API/DMF

API forms an integral part of any submission dossier for a drug product. Active substance master file...

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