Confidence Beyond Compliance
PharmaLex provides support for all aspects of Clinical Trial Applications (CTA) and Investigational New Drug (IND) applications. With our knowledge and experience, you can be confident of meeting your regulatory requirements right from the start.
We support our clients by:
- Coordinating multinational, global submissions.
- Providing strategic advice and guidance on CTA preparation based on market specific expertise, in order to address and minimize the risks of any validation queries or grounds for non-acceptance that may arise during assessment
- Authoring and/or performing the technical review of core documents such as the Protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD) and labeling
- Authoring local documentation
- Supporting translation of documents through our specialist provider
- Compilation and publishing of final submission packages
- Handling the submission process to National Competent Authorities and Ethics Committees.
- Effectively liaising with the authorities to obtain successful conclusions
- Supporting post-submission activities including response to questions, trial amendments (substantial, non-substantial), end of trial notifications
Our worldwide network of regulatory experts and trusted affiliates ensures high-quality, time-adherent Clinical Trial Applications as well as comprehensive management of post-submission activities.