Regulatory
Affairs Support.
Helping you design and implement innovative regulatory strategies
Expertise
Our Leadership team has extensive collective experience in steering products from pre-clinical to commercial manufacture.
Science-led
Our approach is scientific, collaborative and open, ensuring an open dialogue and transparency that fits your project.
Award-winning
We are a leading CDMO recognised for numerous awards including a King's Award For Enterprise.
Nimble
We adapt to your project needs, and pledge to never relegating it to the bottom of the list.
Regulatory Support
Navigating the changing regulatory landscape is an ongoing challenge for many involved in the development, approval, and manufacture of pharmaceutical drug products.
Our experienced team provides dedicated regulatory resources to protect your confidentiality with global expertise and support. Our proactive approach enables early engagement with regulators and flexible options that provide customised submission support.
Our Regulatory Support Services span across clinical trials, classifications and agency interactions support.
Get in touch with our team to learn more.
Clinical Trials
- Writing or review of Investigator Brochure and IMPDs including CMC, non-clinical and clinical sections, clinical protocols.
- INDs/CTAs and amendmentspreparation & submission
- DSURs, Annual Safety reports preparation & submission
Regulatory Strategy, Gap Analysis & Classifications
- Drugs, Biologics, OTC Products, Combination Products
- Development plans, Gantt charts
- Gap analysis for “reborn” projects and / or during due diligence
Regulatory Agency Interactions Support
- Scientific Advice, Pre-IND, EOP2 meetings, pre-NDA/BLA meetings, Protocol assistance
- Orphan Drug Status designation EU & US
- ATMP classification
- PRIME designation, Fast track designation, breakthrough therapy designation
- Marketing Applications (MAA/NDA/ANDA/BLA)
Clinical Trials
- Writing or review of Investigator Brochure and IMPDs including CMC, non-clinical and clinical sections, clinical protocols.
- INDs/CTAs and amendmentspreparation & submission
- DSURs, Annual Safety reports preparation & submission
Regulatory Strategy, Gap Analysis & Classifications
- Drugs, Biologics, OTC Products, Combination Products
- Development plans, Gantt charts
- Gap analysis for “reborn” projects and / or during due diligence
Regulatory Agency Interactions Support
- Scientific Advice, Pre-IND, EOP2 meetings, pre-NDA/BLA meetings, Protocol assistance
- Orphan Drug Status designation EU & US
- ATMP classification
- PRIME designation, Fast track designation, breakthrough therapy designation
Marketing Applications
- MAA / NDA / ANDA / BLA
We're here to help
If you’re looking to work with a CDMO that can support your product from preclinical development to market and beyond, then we’re here to help.
Speak to our team to discuss your requirements.
