Regulatory & Quality

What’s the most efficient regulatory strategy for my medical device or drug? How and when should I plan for a global regulatory strategy?

Is my product a device? A drug? A combination drug/device?

 

Do I need an approved medical device to start a clinical trial for my device/drug combo product?

How do I know my CRO is providing their services at the highest quality?

 

Does my targeted indication meet requirements for orphan drug designation? And can I apply in the US and EU at the same time?

Does my drug or device qualify for expedited development programs like Fast Track or accelerated development status?

 

 

Which licensing procedure do I need to use for my drug in Europe (centralized, MRP, or DCP)? How do they work and what are the timelines?

When and how can I interact with regulatory agencies to discuss regulatory and scientific aspects of my drug development? Which agency should I choose?

 

 

What’s the difference between protocol assistance and scientific advice? How should I prepare for a scientific advice meeting?

Do I need a Paediatric Investigation Plan for my drug? Can I apply for a waiver?

 

 

When do I need to start thinking about electronic submission requirements?

What’s the difference between eCTD and NeeS regulatory submission formats and what does it mean to me?

 

 

How do I apply for clinical trial authorizations in the US and EU? Is there a European IND process?

What is SME status in Europe? Does my company qualify, and how does it save me time and money?

 

 

Is my product eligible for Fast Track?

We have an ISO quality certificate, can we pass an audit from other countries such as the US?

 

 

I want to sell my product world-wide, what kind of approvals/studies/certificates do I need?

What is Quality by Design? (QbD) Why do I need it?

 

 

What standards apply to my product? How can I meet these most cost effectively?

Example of solutions to address the above questions.

Evaluate products (drugs or devices) in relation to the current global regulatory landscape.

Develop regulatory strategies that anticipate and resolve potential challenges, including assessment of applicability of unique programs and pathways available for approval (e.g. SPA, Orphan Drug Designation, fast track, etc).

Manage the regulatory requirements for a product throughout its life cycle with support for variations, line extensions, renewals, PSUR submissions and responses to Authority requests.

Interact with regulatory authorities or prepare in-house teams for presentations, discussions and interactions with regulatory authorities.

Produce or review the full range of clinical and regulatory documents (protocols, statistical analysis and data management plans, CRF/eCRF, CCDS, CSR, IB, HA briefing and response documents, IND, CTA, IDE, BLA, NDA, NDS, MAA, 510(k) and PMA filings, supplements, prescribing information, risk management plans, PSUR, DSUR).

Provide high quality, fully compliant e-publishing services (eCTD, NeeS) and paper submissions.

Train staff or investigators on GMP, GCP requirements.