Direction. Magnitude. Results

Vector CMC Consulting LLC

Direction. Magnitude. Results.

 

Vector CMC Consulting

Vector CMC Consulting LLC was established in 2016 as a 1-person consulting operation to provide my experience in late stage pharmaceutical sciences development toward your project needs.

My technical training is in synthetic chemistry (PhD and postdoc), a key discipline for creating a robust and scalable API (active pharmaceutical ingredient) process that can be relied upon to negotiate the rigors of technology transfer, ICH batch manufacture, process validation, and Regulatory scrutiny to achieve approval followed by commercial supply.

I also have deep industrial experience in leading pharmaceutical sciences project teams to bring new molecules to market. I can help you deliver a strong and coherent data package from across all related CMC (chemistry, manufacturing, and controls) disciplines (chemistry, formulation, analytical, etc.) to be successful. 

 

Contact

☎ CONTACT

tamulhern@gmail.com
(269) 762-9799

 

Areas of Expertise


process chemistry development

Consultation on API route selection, scale-up, optimization, and generation of the right data package to achieve Regulatory approval and reliable long-term supply. Let me put my experience to work for your project.

 


FDA & Regulatory Authority
interactions

Writing and editing portions of Regulatory documents (INDs, NDAs, corresponding EMEA documents); meeting with FDA; responding to queries. Let me apply lessons gained from 5 successful NCE approvals to positioning your project for a successful review.


Regulatory (cmc) project progression

Phase-appropriate (balanced) development to mitigate risks and keep CMC off the critical path; holistic approach to avoid weak links between related areas (chemistry, formulation, analytical, etc.); positioning projects for smooth Regulatory review and approval. I can add value to your CMC development program.


cross-cultural business interations (india, europe, us)

Building high-functioning teams with CRO/CMOs in India; establishing trust, communication, and productive modes of operation. Let me apply my experience to enhance your cross-cultural collaboration.


api due diligence (buying & selling)

Assessing API data packages for depth, quality, and especially, any fatal flaws or potential showstopper issues; identifying ways to fix flaws. Whether you are buying or selling an API asset, getting an experienced process chemistry evaluation can help maximize the value of these big-ticket deals. Let me put my experience to use in your endeavor.


 
 

 
 
Give someone a meal and you feed them for a day.
Teach someone how to cook and you feed them for a lifetime.
— Old adage, slightly modified
 
 

 
 
 

Let's Chat.

Use the form below to contact me for more information or to set up an initial conversation.  regarding your enquiry. You may also email or call to make an appointment.

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