TranScrip Regulatory and Peri-registration Activities

TranScrip have extensive and recent experience in the requirements for, and achievement of, successful regulatory submissions and approvals, whether it be first time applications, renewals, or label extensions.

Expertise
Experience

TranScrip Regulatory and Peri-registration Activities Experts

TranScrip’s Regulatory team has worked on all stages of projects ranging from first time into man through to submissions for regulatory approval and subsequent variations. Whilst reg ops can be undertaken, exploring creative regulatory strategies via focused meetings with health authorities is an important strength. Geographical experience covers, FDA, EMA and PMDA.

Bob Milsted
Head of Regulatory and Peri-registration Activities

As Head of Regulatory and Peri-registration Activities, Bob oversees the regulatory aspects of TranScrip’s projects. His regulatory experience includes leadership of many meetings with FDA, EMA and PDMA. He has been on the board of the ICH working party on the Clinical Trial Report, and was a member of a joint NCI/FDA/ASCO working party on breast cancer prevention. He brings to TranScrip over 30 years of experience, principally in Astra Zeneca and latterly at Celtic Pharma in Clinical and Regulatory Affairs.

Case Study

This case study demonstrates TranScrip’s role in achieving a label indication outside of usual regulatory guidance.

Challenge
A biotech company sought to register an antibiotic for an indication that was not considered acceptable by EU regulatory guidance, using a single small clinical trial in a condition of high medical need.
Solution
TranScrip Partners undertook the preparation of clinical sections of the MAA based on reanalysis of the data package previously submitted to FDA, maintained a close dialogue with agency assessors and key opinion leaders to champion the need in this indication and followed the registration process throughout including support for the oral hearing.
Result
The exact desired label indication was achieved.

TranScrip Partners Regulatory Affairs team together with our therapeutic area specialists provide support that includes:

Regulatory input into global development plans
US, EU & national scientific advice & authority meetings
Regulatory strategy for paediatric and orphan drug development
MAAs, NDAs, CTD modules and management of submission processes
Preparation for CHMP or FDA hearing and appeals
Preparation of CTAs and INDs
Management of variation and renewals
Development of Paediatric Investigation Plans
SmPC harmonisations