If you are not able to access the appropriate expertise in-house, we can help to fill that knowledge gap.
Our wealth of in-depth clinical expertise mean we are able to support you on a wide variety of projects, irrespective of therapeutic area.
Navigating regulatory strategy
You might be in the early stages of regulatory filing or your application may have stalled or, worse, failed. Whatever your situation we have the skills to get your submission moving in the right direction.
We have a long and successful history of working to advance our clients’ programs with regulatory bodies such as the FDA, EMA, MHRA and CHMP as well as many others throughout the world.
We can help you develop a robust regulatory strategy and assist with developing, writing and submitting documents such as, BPs, INDs, CTAs, BLAs, NDAs, MAAs and PMAs.
Our team of CMC and quality staff can help at any stage of development of your drugs, biologics or devices.
In partnership with our sister company (eCTDSubmit) we are fully equipped to collate, compile, publish and submit your eCTD dossier through the FDA’s ESG and provide suitably-formatted submissions for most major countries. We can also help you prepare advisory committees for CHMP and FDA.
If you have a product nearing approval, or if you are reviewing marketing and commercial possibilities, we can ensure you are ready for launch.
We offer pre-launch planning, as well as medical education materials and activities. We can also arrange and run advisory boards and focus groups. And once you have launched we can produce promotional items such as sales aids, digital campaigns, explainer videos and ads.
When you partner with us, our wealth of experience means we can help move your program forward. For example, we can assist you with:+
- Combination products (drug and delivery device)
- Audits (CAPAs)
- Quality consulting
- Statistics and DM
We provide a global perspective from both a clinical and regulatory standpoint. Our MDs and clinical scientists have a wide range of experience covering virtually all medical specialties, including:+
- Emergency medicine
- Infectious diseases
- Metabolic disorders
- Respiratory medicine
- Urology Vaccines
With our thorough and far-reaching knowledge of clinical development we can assist your organization with:+
- Clinical operations
- Companion diagnostics
- Device development
- Drug and biologic development
- KOL management
- Medical affairs
- Medical writing
- Patient-reported outcomes
- PR & sales
- Preclinical disease models
- Quality systems
- Specialist team recruitment
Medical writing support
Medical document writing is a key part of our business. We have expert writers around the globe, so whatever your location we have the know-how to meet your requirements. We are able to plan, prepare and disseminate a wide range of documents, including:+
- Clinical evaluation reports
- Clinical modules
- Conference reports and transcripts
- Literature reviews
- Marketing plans
- Non-clinical reports
- Regulatory submission & revision
- Study publications
Our expertise in due diligence stands up to close inspection. We are able to provide assessments across all areas of due diligence including: manufacturing, technology, market access, commercial opportunities, orphan strategy and accelerated proof-of-principle designs.