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Services

Beyond CMC was established to help startups in Drug Development with their Regulatory Affairs and CMC Development- through courses, workshops,  and hands-on services- all provided directly by me, Raz Eliav.

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I offer:

  • Hands-on Regulatory and CMC support to your project, as a flexible scope team member

  • Strategic consulting

  • Professional training to teams

  • Knowledge management as-a-service, and digital transformation projects

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I have experience with a wide array of product modalities- small molecules, biologicals, gene and cell therapies and more, at all clinical development stages.

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Please refer to the different service packages below, and feel free to reach out to tailor your optimal solution!

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Hands-on and strategic support

CMC Development, Operations and Regulatory Affairs

I can help you with the day-to-day operations and strategic decisions relating to CMC Development and Regulatory affairs, for example:

  • Support with outsourced operations - Selection and management of manufacturing operations with CDMOs and other service providers

  • Manage CMC development activities such as tech transfers, Comparability, Analytical and Process development studies, etc.

  • Establish and operate a phase-appropriate CMC development strategy

  • Science and Risk-based CMC troubleshooting- accommodating the "right thing to do" with the Startup reality and constraints

  • Regulatory-CMC support, i.e, regulatory strategy, authoring regulatory  submissions and lead consultation meetings with the authorities

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Service packages:

  • Intro meetings and off-the-record advice are free of charge- please feel free to reach out!

  • Hourly basis:

    • For short-term and occasional engagements 

    • Cost: 375 EUR / hour

    • Free of charge monthly touch-base for dormant projects 

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  • FTE Basis (Currently unavailable)

    • Get all my offerings on a regular basis (hands-on, strategy and training)

    • a baseline capacity is reserved for your project (no upper limit-  depending on my availability I'm happy to engage as much as possible with your project)

    • Cost: 5250 EUR / month, per 20% FTE baseline (~1 day per week)

    • Increased baseline commitment (up to full-time commitment) can be commissioned in 20% increments, pending availability

    • Travel costs are billed separately

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  • Advisory retainers (Currently unavailable)

    • Regular weekly meetings for discussion and maintenance of your project knowledge base

    • Open line (and inbox) for ongoing questions dilemmas (same or next day response, complex topics to be discussed in the weekly meeting)

    • Cost: 2950 EUR / month

    • Additional services:

      • Project-specific knowledge map ("Second Brain") living inside your company's data system - included

      • Project-specific training seminars, onboarding and investors meetings - quote on demand

      • Review and authoring of Regulatory and technical documents - quote on demand (pending availability)

Dedicated CMC and RA Training Courses

Beyond CMC offers a rich portfolio of CMC Training courses, which can be tailored to:

  • Your  team's needs

  • Your specific product modality

  • Your stage of development (from Bench to Commercial)

  • Your type of business (Startups, CDMOs and other service providers, Software developers, etc.)

Service packages:​

  • Smaller teams and individuals- please refer to our online school page for public courses and on-demand materials (more cost-effective)

  • For Bigger teams (no size limit):

    • A tailored training course custom-built to your needs (i.e. product modality or in-house technologies (for CMOs), stage of development, number of sessions and curriculum)

    • Includes:

      • ​Company-dedicated learning portal, with an integrated  Learning Management System (includes certification, reporting, Q&A forum, all course materials  and extra resources)

      • Edited session recordings optimized for on-demand watching  (short length, subtitles and transcript). Ideal for future onboarding of team members, service providers and consultants.

      • Monthly follow-up sessions for Q&A (for several months, in accordance with course duration)

 

​Cost:  from 2500 EUR*

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* Final cost depends on course length, to be tailored to the situation and team- typically, courses span 5-10 sessions, and an optimal session is ~2 hrs long. Session recordings remain available in the training portal and are split to 15-20 minutes mini-sessions, per topic.

Knowledge Management and Digital Transformation

Establish an in-house practice and systems for Knowledge management and /or initiate your digital transformation, as we step towards the Regulatory requirements of tomorrow.

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Scope and quote to be issued on a case-by-case basis- let's talk to first understand where you stand!

CTD Module 3 workshop

Do you have a clinical trial in the horizon?  Or an advice meeting with the authorities?

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Module 3 of the CTD tells the full story of product quality and manufacturing.

It is an essential part of all regulatory submissions.

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In this interactive workshop I will guide you step by step in writing the first drat- this will:

  • Save your project time and money when onboarding the Regulatory consultants to finalize it

  • Give you a solid understanding of your CMC Development portfolio- what's there and what's still missing (depending on your stage of development)

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