KEY SERVICES:
- EU and UK Clinical Trial Applications (CTA) guidance
- Scientific Advice briefing and meeting support
- IND CMC dossier preparation (Modules 2 and 3)
- MAA guidance and preparation
- Development and Lifecylce Regulatory Strategy
- Labelling strategy guidance
- Annual Reports and Variations planning change control
- AI Regulatory intelligence
Illustrative Case Study:
The following example illustrates how InsightReg would approach CTA readiness for a growing biotech preparing for early-phase clinical trials.
- Client Type: Early-stage biotech developing an autologous cell-based immunotherapy
- Product Type: Cell therapy considered an ATMP
- Phase: First-in-human trial planned in the UK
- Key Challenges: -
- Limited in-house regulatory capability
- Underdeveloped CMC documentation (Module 3)
- Need for UK legal representation
- Unclear GMP and comparability strategy
KEY SERVICES:
- Reviewing and Authoring SOPs
- Proofreading existing documents for accuracy and clarity
- Regulatory writing support for eCTD-ready documentation
Illustrative Case Study:
The following example illustrates how InsightReg would approach SOP development for a growing biotech preparing for early-phase clinical trials.
- A UK-based virtual biotech developing an mRNA immunotherapy engaged InsightReg to build a compliant SOP framework in preparation for their first-in-human EU clinical trial. With no QA team in place and loosely defined procedures, the company needed rapid support to meet regulatory expectations.
KEY TRAINING TOPICS:
- Regulatory Affairs Career Talks for Universities – Delivered Online
- CMC Drug Development & Lifecycle Management
- CTA regulatory pathways and strategy
- Borderline product classification
- Cosmetics regulations
- Medical devices regulations
- Small molecues versus large molecules
- Cell and Gene Therapy
Illustrative Case Study:
The following example illustrates how InsightReg would deliver virtual training courses.
- A UK university partnered with InsightReg to deliver a virtual training course introducing students to careers in regulatory affairs.