Development/
R&D Phase
We help clients to navigate and optimise their development seamlessly, maximising the chance of success for new medicines.
Product Development
- Plan your route from early product development to product approval.
- We can work on the whole development programme or provide expert guidance in specific areas.
- Our expert team can keep you focused on the end goal by advising you on the ultimate regulatory pathway in terms of speed and efficiency.
Scientific Advice Meetings
- We provide pre-SA(Strategic Advice) and craft the questions that needs to be asked.
- Supply experts to support your application (pre-clinical, quality, medical etc)
- Liaise with Health Authorities (from pre-submission to post-SA follow-up)
Clinical Trial Application / Early Access
- Preparing, submitting and co-ordinating your CTA activities.
- Reviewing your CTA submission documentation (‘gap analysis’)
- Authoring your IMP Dossier (IMPD)
- Maintaining your CTA (substantial amendments, end-of-trial declarations, etc.)
Orphan Drug Designation
We have plenty of experience in obtaining orphan drug designation (ODD) and can advise you on all regulatory aspects related to Orphan Drug approval.
Regulatory Strategy
- The regulatory environment is complex and presents a multitude of options, and opportunities to optimize the development of products.
- We have an extensive understanding of the global regulatory environment for medicines to develop and implement creative and innovative strategies to maximize the long-term success.
PIP Applications
- Throughout development, frequent interaction with global regulators enables optimisation of development and maximises the chances of success for medicines.
- We have expertise in defining the optimal strategy and the process of regulatory advice meetings.
