About Our Company
Who we are
- A small consultancy which has a consortium of consultants worldwide with a focus on small, virtual companies as well as large pharmaceutical firms to ensure timely and approvable submissions to Regulatory Authorities in the US and Europe
- Member of Expert panels and provider of targeted pharmaceutical training for both small companies and big Pharma
- Develop and deliver training courses for companies customized for the client needs
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Our Experience
Proven ability to:
- Work as a part of internal project teams and manage virtual teams
- Manage multiple CRO’s contributing to projects
- Assemble the highest caliber teams of experienced pharmaceutical professionals including CMC experts for both API, drug products and biologics, medical writers, statisticians, and auditors for manufacturing plants
- Work with multiple review divisions within CBER and CDER as well as the EMEA and Competent Authorities in Europe for Scientific Advice Meetings, preparation of Centralised, Decentralised, Mutual Recognition and National submissions
- Develop and deliver training programs based on company needs from our over than 160 different course modules
More about Carolyn Hoskins Kruse, Founder |
What we deliver
- On time quality submissions
- Teams comprised of experienced professionals including CMC experts for small molecules and biologics including preparation of the Module 2 QOS and Module 3, medical writers for the preparation of protocols, clinical study reports, Module 5 as well as the Module 2 Clinical Overview and Clinical Written Summary, Nonclinical experts for the preparation of toxicology protocols, toxicology reports, preparation of Module 4 and the Module 2 Nonclinical Overview and the Nonclinical Written Summary, Statisticians for the analysis of both clinical study data as well as stability data
- We insure a consistent message across documents which supports statements in the Package Insert (PI, labeling) and the EU Summary of Product Characteristics (SmPC)
- Maximized efficiency by working in different time zones
- A consistent team to provide continuity and to prepare all documentation required for regulatory submissions
- Customized training courses in drug development for US and global markets
Our Track Record >
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