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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

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

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

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

Service packages:

  • Hourly basis:

    • For short-term engagements 

    • Cost: 200 USD / hour

    • First meetings, and occasional off-the-record advice are
      always FREE- schedule here

  • FTE Basis (Currently unavailable, inquire for Q4 2024 onwards)

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

    • Reserve a minimum capacity​ to your project (no upper limit-  depending on availability I'm happy to engage as much as possible with your project)

    • Cost: 3500 USD / month, per 20% FTE commitment (1 day per week)

    • Increased minimal commitment (up to full-time commitment) can be commissioned, pending availability
    • Travel costs excluded

  • Advisory retainers:

    • Regular weekly meetings for discussion and knowledge mapping

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

    • Cost: 1750 USD / month

    • Additional services:
      • Online access to project-specific knowledge map- included 

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

      • Review and authoring of Regulatory and technical documents-
        quote on demand

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: 2500 USD / session*

* Number of sessions per course, and session length to be tailored to 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.

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?

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

It is an essential part of all regulatory submissions.

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)

Read more and register....

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