Confidence Beyond Compliance
PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.
With our global understanding, we are with you every step of the way. The PharmaLex team 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. Our network of regulatory experts and trusted affiliates deliver high-quality time-adherent CTA and IND applications, as well as comprehensive management of post-submission activities.
Alongside large pharmaceutical companies, we work with SMEs (including start-ups), virtual operations and academics, and have experience in a wide range of therapeutic areas and dosage forms.
You can be confident of meeting your clinical trial regulatory requirements during your development journey with our specialist support and advice.
- Coordinating multinational, global submissions
- Providing strategic advice and guidance on Clinical Trial application 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 market-specific and local documentation, including 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/or 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
- Creating a Target Product Profile (TPP)
- Designing and developing individual protocols/synopses
- Authoring and/or performing the technical review of core documents such as the Protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD), and labeling
- Conducting gap analyses of existing documentation to provide guidance on outstanding requirements and supporting the closure of identified gaps
- Authoring of EU and US pediatric plans, waivers, and deferrals
- Authoring clinical study reports
- Managing the overall clinical development program and monitoring progress and budget
- Identifying and managing the clinical program risks and issues and taking corrective actions
- Coordinating the projects and vendors required for the clinical program and their interdependencies and managing resources across projects
What our clients say
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
VP Regulatory Strategy
Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.
Senior QA Associate