1. We want to partner with you!
We Focus On
Cradle to grave drug product
development
Scale up and commercial
manufacturing
GMP related activities
CMC FDA filings
Consulting with on site
participation as needed
Contact Us
Email:maryellen.lavin@aya.yale.edu
www.linkedin.com/in/maryellenlavin2013
CMC DEVELOPMENT LLC
Partners in Drug Development
Paramus NJ 07652
CMC
DEVELOPMENT
Advantages of working with us
 We work when you need us
 We allow you to grow your
business without growing
your staff
 We have an extensive
network in the industry
 Easy to work with
 Driven
 Focused on the timeline
 A quality organization of
gifted problem solvers
What Collaborators said about
CMC Development
 Apt at connecting scientific
disciplines: formulators,
analytical/characterization,
clinicians, and CMC
regulatory specialists
 Push deadlines, and ensure
your project is on track
 Fast friendly service
We aspire to assist you
leveraging our
experience & technical
depth
in your CMC product
development and
regulatory needs
We are

2. CMC Development
Your Trusteed Experienced Partner
Design Space
Normal Operating Range (NOR)
Proven Operating Range (POR)
o Critical Process Parameters (CPP)
o Critical Quality Attributes (CQA)
o Critical In-Process Controls (CIPC)
o Current Good Manufacturing Practices
(cGMP)
Roller mill and High Shear Granulator
Certified in Clinical Development and
Regulatory Affairs
Author of CMC documents
successfully filed with the FDA
Experience in
INDs
NDAs
PAS
ANDAs
CBE 30s
Annual Reports
Wet Granulation
Dry Granulation
Lyphilization
High Pressure Homogenization
Annular Gap Mills
Extrusion
Tableting
Unit Operations Experience
Extensive record of formulation
and commercial product
development.
o Manage product development cross
functional projects
o Knowledge of Life Cycle Management
opportunities and challenges in these
therapeutic areas:
Atherosclerosis & Cardiovascular
Respiratory
Neuroscience
Diabetes
Infectious Diseases
Oncology
o Experience in end to end drug development
o Formulation Tool Kit includes:
Suspensions
Emulsions
Orally dispersible tablets
Immediate and controlled release tablets
Hot Melt Extrusion
Convection Enhanced Delivery