Confidence Beyond Compliance
PharmaLex provides support for all aspects of Clinical Trial Applications (CTA) and Investigational New Drug applications (IND) and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.
The PharmaLex team is with you every step of the way and with our global understanding we can strategize and support multi-market and regional programs to meet your study needs, as well as helping you build a positive relationship with national competent authorities and ethics committees.
Alongside large pharmaceutical companies, we also work with SMEs (including start-ups), virtual operations and academics, and have experience in a wide range of therapeutic areas and dosage forms.
With our specialist support and advice, you can be confident of meeting your clinical trial regulatory requirements during your development journey.
We provide Clinical Trial Application support and IND support to 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
- Clinical trial design
- Conducting gap analyses of existing documentation to provide guidance on outstanding requirements and supporting the closure of identified gaps
- 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 market specific and local documentation
- Providing local intelligence for the adaption of core patient facing documents, such as the Informed Consent Form (ICF)
- Supporting translation of documents through our specialist translation partner
- Compilation and publishing of final submission packages
- Handling the submission process to National Competent Authorities and Ethics Committees according to local requirements
- Effectively liaising with the authorities to obtain successful conclusions
- Supporting post-submission activities including response to questions, trial amendments (substantial and non-substantial) and end of trial notifications
PharmaLex has a network of regulatory experts and trusted affiliates, ensuring that we can assist our clients with a wide range of activities associated with CTA and IND applications. The worldwide regulatory team delivers high-quality time-adherent Clinical Trial Applications as well as comprehensive management of post-submission activities.