Solutions
Product Development & CMC
Build a strong CMC foundation that successfully carries your product from innovation to launch
CMC is the foundation everything else is built on.
During product development, CMC is too often treated as something to assemble once the science is settled and the filing comes due. But in practice, your CMC package is made up of decisions made across the development process.
Those decisions either hold up under scrutiny, or they don’t—but the consequences can be far-reaching.
A process that worked at small scale can’t be reproduced at commercial volume. An analytical method can’t transfer to your CDMO. A reviewer asks for a justification you can’t provide. That’s when filings stall, supply gets delayed, and the timeline you gave your board begins to stretch longer and longer.
But what if your CMC strategy was developed alongside your science to support it every step of the way?
Advance Pharmaceutical Product Development with Pharmatech Associates
Pharmatech Associates designs product and process control strategies with a clear line of sight to quality and regulatory requirements—so what you prove in development is what you can defend at commercial scale.
We build programs that are:
- Defensible
- Submission-ready
- Built to scale
With over 30 years’ experience in drug development, CMC, and GMP execution, our senior-led teams help life science companies get pharmaceutical CMC right the first time.
Pharmatech Associates Helps You:
Reduce Risk
Anticipate scale-up, tech transfer, and integration challenges before they reach the plant—not after.
Strengthen Submissions
Build a CMC package with the data, rationale, and documentation reviewers require.
Protect Timelines
Keep clinical and commercial milestones on schedule with hands-on support at every transition point.
Control Costs
Senior-led, focused assessments replace broad risk lists, which leads to sharper analysis and fewer late-stage surprises.
What You Get
Integrated Control Strategy
Product, process, analytical, and device integration aligned within a single lifecycle framework.
Expert-led Assessments
Focused analysis from pharmaceutical experts with FDA and regulatory backgrounds.
Submission-Ready Documentation
Data review and section authoring that gives reviewers a clear, complete argument.
Scale-Up Confidence
Development work built to withstand multiproduct operations, global supply networks, and post-approval change.
Over 30 Years’ Experience
Guidance from people who understand exactly what agencies look for.
Digital Capability
In silico modeling, analytics, and Pharma 4.0 tools applied where they shorten your path.
Our Product Development & CMC Services
CMC Strategy and Submission
Your CMC section is the argument for your product’s quality. We help you build it deliberately: defining the strategy early, then generating and organizing the data that supports it.
- CMC and regulatory submission strategies
- Data review and section authoring for INDs, BLAs, and NDAs
- Comparability strategy and justification
- Regulatory response and agency interaction support
- Alignment with FDA, EMA, and ICH expectations
Control Strategy and Development Support
Pharmatech creates an effective control strategy that integrates product, process, and analytical development with clear line of sight to quality and regulatory requirements.
- Process and analytical control strategies
- Quality control laboratory and method lifecycle management
- Critical material and vendor management
- Equipment design and validation
- Device integration and combination product support
Scale-Up, Tech Transfer, and Commercial Readiness
Scaling to commercial production often involves tech transfer, CDMO oversight, or vendor transitions. Each step carries risk if it isn’t managed carefully. We start with a gap analysis of your controls, procedures, and process maturity against global expectations, then build the roadmap and provide hands-on support to execute it.
- Gap analysis against global regulatory expectations
- Roadmap development for clinical and commercial milestones
- Tech transfer planning, protocols, and batch records
- CDMO selection oversight and readiness activities
- Process validation strategy and execution support
Case Studies
Comprehensive Assessment Leads to FDA Alignment
- Biosimilarity successfully demonstrated
- Robust control strategy established
- FDA alignment achieved without delays
Redevelopment Success Without FDA Findings
- Three INDs advanced successfully
- Zero FDA observations during audit
- Development continued without disruption
Eight Programs Transferred Without Delay
- All eight programs successfully transferred
- Regulatory alignment maintained
- Audit-ready transition completed on schedule
Build a development program that holds up
You don’t have to solve your product and CMC alone. We’ve taken products from early innovation through commercial launch before, and we know where programs get stuck. As a USP company, we bring standards-setting perspective and deep relationships with former FDA reviewers to every engagement. We’ll help you prepare for what agencies expect instead of reacting to their findings.
Tell us about your program. Within hours, you’ll be on a call with subject matter experts who can pinpoint your challenges and map a path forward.
Frequently Asked Questions
What is CMC in pharmaceutical product development?
CMC—chemistry, manufacturing, and controls—is the body of data and documentation that demonstrates your product can be made consistently, at quality, at scale. It covers your manufacturing process, analytical methods, specifications, stability, and control strategy. Strong pharmaceutical CMC work is what allows a reviewer to conclude that the material used in your clinical trials is the same material you’ll commercialize.
When should we start thinking about CMC strategy?
The timelines vary, but earlier than you think. Decisions made in early development—cell line, process design, analytical methods, material sourcing—determine what you can defend later. Bringing CMC strategy in early costs far less than reworking things after a filing stalls. However, if you’re already further along, a focused gap analysis will tell you where you stand and how to get back on track.
What does “data review and section authoring” actually involve?
We review your existing development and manufacturing data for completeness, consistency, and defensibility, then author the CMC sections of your submission—Module 3 and the relevant quality summaries. The goal is a package that presents a coherent argument rather than a collection of reports, so reviewers can follow your rationale without asking for it.
How do you support tech transfer to a CDMO?
We manage the technical risk, not just the logistics. That includes risk assessments, protocol and batch record authoring, method transfer, comparability planning, and oversight of readiness activities at the receiving site. We’ve transferred programs across sites and organizations without losing regulatory alignment or schedule.
Can you help us prepare for a pre-IND or Type B meeting?
Yes. We help you frame the CMC questions worth asking, build the supporting data package, and prepare your team for the discussion. Well-prepared agency interactions are one of the highest-leverage investments in CMC drug development—they surface misalignment while it’s still inexpensive to correct.
Our development program is moving faster than our CMC work. Can you help us catch up?
This is common, and it’s fixable. We assess where your data package stands against where your program is headed, prioritize what has to close before your next milestone, and put senior resources on the critical path. In many cases, we can begin within days.
Do you work on small molecules, biologics, or both?
Both, along with cell and gene therapies and combination products. Our teams include experts across modalities, and we match the right expertise to your product rather than applying a single template.
How do you approach analytical method development and lifecycle management?
Methods need to be developed with their entire lifecycle in mind—validation, transfer, and eventual change. We support method development, qualification and validation, transfer between labs, and ongoing lifecycle management, including quality control laboratory strategy and oversight of contract testing.
What’s involved in a development gap analysis?
We assess your controls, procedures, and process maturity against global regulatory expectations, then deliver a ranked roadmap showing where you’re exposed and what to address first. It’s a focused assessment led by senior practitioners—not a broad risk list that leaves your team to sort out priorities.
Can you support post-approval changes and continuous improvement?
Yes. A well-built control strategy anticipates change. We help you plan and justify post-approval changes, manage comparability, and implement process improvements without disrupting supply or triggering avoidable regulatory burden.
How quickly can you get started?
We’re built to move fast. In many cases, we can begin within days—and we can get you on a call with an expert within hours of connecting with us.
