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...