An accurate and deep understanding
We understand that your journey from discovery to approval can be challenging. This is why we believe that even at proof of concept stage, expert advice can mitigate project risks. Whether you prefer "pay as you go" ad hoc advice, or a full fixed fee project management service, we can help. Wherever you are in your journey, reach out to us and let's explore how we can optimise your chances of regulatory success together.
With so many options, steps and procedural complexities throughout development and during registration, choosing your regulatory strategy can be a daunting task.
We can clarify the options, advise on the best solution, and design and implement the best roadmap for your product.
CMC aspects are critical at all stages of product development, from first in humans stage of development to activities such as cost optimisation post marketing.
We can advise and support at all stages of development to ensure a smooth path to approval at each step in your product's journey.
CLINICAL AND NON-CLINICAL
We have a network of highly experienced ex-Regulators who would be delighted to support your Non-Clinical and Clinical activities.
- Regulatory strategy
- Orphan Drug Designation
- Scientific Advice procedures
- Preparing for MAA submission
- Choice of MAA legal basis and procedure
- Life cycle maintenance
- Gap analysis
- Dossier Authoring
- Technical advice and troubleshooting
- Quality by Design and Real Time Release Testing
- Rapid Microbial Methods
- ATC code applications , Scientific advice briefing, book authoring and review
- Development roadmaps
- Scientific advice
- Clinical trial design
- PRIME eligibility request
- Gap analysis
InsideReg is a CMC and regulatory affairs consultancy based in Switzerland, founded to support pharmaceutical companies of all sizes, on their journey to approval at every stage of product development
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