Our Services

At Nexus CMC Advisors, we provide a comprehensive range of Chemistry, Manufacturing, and Controls (CMC) consulting services designed to support lean regulatory CMC teams engaged in the clinical stages of small molecule, peptide, or oligonucleotide drug development. Whether you are advancing a novel therapeutic through early clinical trials (IND) or preparing for a marketing application submission (NDA/BLA), our expert team offers tailored regulatory solutions to ensure compliance with U.S. FDA requirements.

Our deep expertise in synthetic peptide, oligonucleotide, and small molecule therapeutics, combined with a focus on quality, allows us to address even the most complex challenges. From strategic regulatory planning to managing compliance audits, we are committed to guiding your product through each phase of development, helping you bring innovative treatments to market efficiently and successfully.

Explore our specialized services below to learn more about how we can support your CMC needs.

The individual services above are packaged into retainers to fit your needs and level of support. Additional details are provided following a free scoping call to assess your needs.

Access

Hours Included: 20 hours/month

Services Included:

1. Regulatory strategy consultation (up to 2 meetings/month)

2. High-level review of regulatory submission sections and technical documents

3. Ongoing email support for CMC-related inquiries.

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Priority

Hours Included: 40 hours/month

Priority 1 Services Included:

1. Attendance in bi-weekly regulatory or internal team meetings

2. Regulatory strategy consultation (up to 2 meetings/month)

3. Review of regulatory submissions and technical documents

4. Ongoing email support for CMC-related inquiries

5. Preparation or review of IND or NDA Module 3 eCTD sections

Priority 2 Services Included:

1. Regulatory CMC strategic leadership (up to 2 meetings/month).

2. Development and/or review of IND Module 3 plans

3. DS/DP vendor coordination (eg, meetings, timeline tracking).

4. FDA meeting prep support

5. Document review (20 pages/month included). Including review of analytical methods, specifications, formulation approach, CDMO technical package.

Executive

Hours Included: 70 hours/month

Services Included:

1. Attendance in bi-weekly regulatory or internal team meetings.

2. Regulatory strategy consultation (up to 2 meetings/month)

3. Review of regulatory submissions (eg, RTQs, briefing packages) and technical documents (eg, analytical method procedures validation/transfer reports).

4. Ongoing email support for CMC-related inquiries

5. Preparation or review of IND or NDA Module 3 CTD sections

6. Dedicated project management support for ongoing submissions (if needed).

7. Real-time consultation during critical project milestones (e.g., pre-IND meetings, type C meetings).

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Services Not Offered At This Time

Please note that the following services are not directly offered at this time, but we may assist you in finding the right partner:

Publishing activities
Device component strategy or authoring
Formulation development assistance