Build the regulatory case behind your development programme
A solid regulatory strategy, defined in the earliest stage of your programme helps ensure a smooth path to and through the clinic. Our drug development team are here to help, ensuring that a fully compliant solid regulatory strategy is incorporated from the get-go, starting with the development plan.
We don’t only know the regulations inside out, we understand how to apply them to your unique therapeutic product and solve any issues that may come up along the way.
Our regulatory experts work alongside your team from the beginning. We help shape the development plan, clarify the regulatory position, support early interactions with the regulators (including scientific advice, pre-IND, INTERACT and ITF meetings), and generate all the documents required for your clinical trial application.
From scientific questions to regulatory advice
Prepare
Our experts audit your current data package, identify regulatory questions based on defined clinical milestones and define what you need from the agency interaction.
Engage
Our team generate the briefing package, including regulatory questions along with the company’s positions. We will file the dossier with the regulatory agency(ies) and prepare you for and actively participate in the meeting.
Act
We prepare the meeting minutes and interpret the agency’s feedback, update the regulatory strategy and translate their expectations into clear development actions.
From regulatory advice to clinical trial application
01. Regulatory pathway planning
02. Scientific advice preparation
03. Operational support
04. Critical gap analysis
05. Clinical trial application
06. Authority response management
Regulatory decisions need developers who understand the science
Regulatory affairs require people who understand how pharmacology, toxicology, CMC and clinical decisions fit together, and how authorities are likely to assess them. Our developers bring hands-on experience across product types, development stages and regulatory pathways. They identify the question behind the question, challenge weak assumptions and turn complex evidence into a clear regulatory position. You work directly with our senior development experts who stay with you from early strategy definition through to agency interactions and submissions.
Support for key regulatory milestones
Our support can include:
- Scientific advice and pre-IND briefing packages
- Investigator’s brochures (IB)
- Investigational medicinal product dossiers (IMPD)
- Investigational new drug (IND) Application
- Common technical document sections
- Orphan drug designation applications
- Paediatric investigation plan (PIP) and initial Paediatric Study Plan (iPSP)
- Product and ATMP classification requests
- Responses to regulatory authority’s RFIs