CMC Development & Supply Chain

CMC is the most underestimated risk in drug development. More programs are delayed by manufacturing and analytical issues than by clinical failures – yet CMC strategy is often treated as a late-stage activity. PLG integrates CMC planning into your development strategy from day one, ensuring that your manufacturing process, analytical methods, and supply chain are submission-ready when your clinical data is. You’ve invested years perfecting your science. Don’t let manufacturing delays derail your timeline. 

• Integrated CMC roadmaps aligned to IND, CTA, NDA, BLA, and MAA timelines 
• Process development strategy and CDMO accountability frameworks 
• Analytical method development, validation, and transfer oversight 
• Formulation strategy and comparability protocol design 
• Tech transfer governance — from development lab to clinical and commercial manufacturing 
• ICH Q8/Q9/Q10/Q11 compliance and quality-by-design implementation 
• CMC module authoring for all regulatory submissions 

• CDMO selection, qualification, and ongoing performance governance 
• Raw material sourcing risk assessment and mitigation 
• Clinical supply logistics  
• Batch release oversight and quality event management 
• Cost-of-goods optimization without compromising quality 
• Scale-up planning from Phase 1 through commercial launch 
• Supply chain continuity planning and risk de-risking 

We know what keeps you up at night: Will your manufacturing be ready when your clinical data is? Will a CMC deficiency delay your submission? Will your CDMO deliver on time? Our senior CMC experts become an extension of your team – building defensible strategies, enforcing CDMO accountability, governing tech transfers, and ensuring every development decision aligns with FDA/EMA expectations. You get robust, scalable processes that meet regulatory standards, accelerate submissions, and position your program for approval – not delays. 

You can’t afford manufacturing delays if a raw material vendor fails or a CDMO misses a deadline. Your clinical timeline, budget, and program value all depend on infrastructure that is often beyond your control. We change that by taking full control of your supply chain, so you can focus on advancing your molecule. From raw materials to global distribution, we make sure the vendors, capacity, and logistics you need are ready when you need them. 

We choose and manage your CDMOs to fit your timeline. We spot and address raw material risks before they can affect your supply. We handle tech transfers carefully so nothing is missed. We supervise batch releases and manage clinical supply logistics with the accuracy your program needs. We also work to lower your cost of goods without sacrificing quality, because both your patients and regulators expect the best. 

The result: a reliable supply chain that protects your timelines, budgets, and program value. There are no surprises or delays, just scalable infrastructure that grows with you from first-in-human trials to commercial launch.