Regulatory services

Jubilant Pharmaceuticals has a dedicated team in Europe, who are specialists in regulatory affairs of generic medicines.

Since 1993 more than 500 national filings, over 100 Mutual Recognition Procedures (MRP) and in addition several Decentralized Procedures (DCP) have been conducted.

Therefore, we are also a preferred partner for all types of regulatory affairs services which are outsourced by our customers.

We advise generic companies in regulatory strategies and compliance requirements, interpreting regulations and writing and reviewing submissions in any EU member state.

As expert consultant in regulatory affairs, we assist at any level of the registration route in Europe to ensure regulatory compliance.

Our expertise ranges from pre-submission activities such as scientific advice or identifying the optimal registration strategy in EU through National, MRP, DCP, Centralized and Abridged applications.

Thereafter, the full dossier preparation is managed from raw data to compliant modules 1-5 in CTD format, including:

• All required expert reports as Quality Overall Summary (QOS)
• Clinical and non-clinical expert reports accompanied with expert signatures recognized by EU authorities
• Conversions from CTD to e-CTD when CTD dossiers are available

During registration, our dedicated team ensures a smooth submission of the e-CTD application and an evaluation of the responses to agency questions until granting of the Marketing Authorisations.

Finally, our regulatory services can also be extended to the following post-approval activities:

• Variations
• PSUR writing
• Line extensions
• PIL readability tests
• Full life cycle management of the dossier
• etc