CMC Consulting for Biotech & Pharma
CMC strategy touches every stage of drug development, and getting it wrong costs time, money, and regulatory goodwill. Whether you're standing up a CMC function for the first time, preparing a submission package for an IND, or designing a supply chain ahead of commercial launch, the expertise you need is specific to your modality, your stage, and your regulatory pathway. CMC challenges in gene therapy manufacturing are fundamentally different from those in small molecule scale-up, and generalist support rarely serves either well.
Alacrita's model, a senior core team plus a curated group of specialist consultants who work for the firm, is what allows us to provide that specificity. We match consultants to your exact situation: analytical method development for a small molecule IND, process optimization for a biologic heading toward BLA, manufacturing strategy for an autologous cell therapy. Across pharmaceutical development and formulation, CMC regulatory strategy, quality management, cGXP compliance, and supply chain.
When a program calls for it, CMC consultants work alongside Alacrita's clinical, regulatory, and preclinical specialists, keeping CMC decisions aligned with the broader development plan.
If you're early-stage and building your CMC function from scratch, we can help you get the foundations right. If you're mid-stage and preparing for a regulatory milestone, we can fill specific gaps in your team's expertise. If you're approaching launch, we can design the supply chain. We also provide CMC due diligence for investors and acquirers evaluating manufacturing and supply chain risk.
CMC Capabilities
Every project is scoped to what the situation requires: a single consultant for a targeted review, or a broader group when the program needs cross-functional expertise.
Pharmaceutical Development Strategy
Get your manufacturing process from early development to submission-ready. We work with you on process characterization, analytical method development, formulation strategy, and tech transfer planning, applying quality by design principles and helping you get the most from your CDMO/CMO relationships.
CMC Regulatory Support
Prepare and submit your IND, NDA/BLA, or CTA with confidence. Our consultants conduct high-level CMC regulatory reviews to identify potential issues before they become problems, prepare submission packages, and support your agency interactions in the US, Europe, and other territories. This includes the additional complexities that biologics and cell and gene therapies present, such as manufacturing process changes for autologous products.
Quality Management Systems
Build an effective quality management system and prepare for cGMP inspections with the FDA and EMA. This can include SOPs, quality agreements, QA governance frameworks, and document management systems. Particularly relevant if you're an early-stage company building these functions for the first time, often ahead of a first GMP inspection.
cGXP Compliance & Audits
Ensure your manufacturing operations meet regulatory standards. Our QA consultants conduct facility audits, CDMO site assessments, and gap analyses, both on-site and remote, for preapproval inspections and ongoing compliance.
CMC Due Diligence
Understand the manufacturing risk in a transaction before you commit. We review manufacturing processes, analytical data packages, stability programs, and supply chain readiness, identifying issues that may affect the deal and providing risk mitigation strategies. CMC due diligence is often part of a broader multidisciplinary assessment alongside clinical and regulatory DD.
Supply Chain Strategy
Design your commercial supply chain for US and EU launch. We integrate regulatory, tax, quality, and logistics considerations, covering distribution licensing, GDP compliance, serialization, packaging configuration, inventory strategy, and 3PL vendor selection to balance compliance, cost, and speed to market.
Interim CMC Leadership
If you're a virtual or early-stage biotech that needs senior CMC leadership but isn't ready to hire full-time, we can provide a consultant who serves as your Interim VP CMC. They set up your initial CMC activities, establish quality systems, manage your CDMO relationships, and help build your internal team. Typically a flexible arrangement scaled to your company's stage.
How We Deliver CMC Expertise
CMC projects vary widely in scope, and Alacrita scales accordingly. Every project starts with the specific expertise required, not a fixed delivery model.
A discovery-stage microbiome company needed to build its CMC function from scratch. Alacrita provided a senior biologics manufacturing specialist as Interim VP CMC, who set up fermentation, harvesting, and cryo-preservation processes, established quality systems, and recruited the initial CMC team.
A gene therapy company in IND-enabling studies engaged Alacrita for ongoing, as-needed CMC and regulatory oversight: CDMO site audits, batch record review, process development oversight, QA/QC review, and IND preparation, with involvement that flexed based on program milestones.
A biopharma preparing for dual US and EU commercialization of an orphan drug engaged Alacrita to deliver integrated supply chain, regulatory, and quality blueprints, covering country-by-country regulatory requirements, SOPs and quality agreements, and a supply chain designed for 24-hour delivery to all treatment centers.
Case Studies
Recent CMC engagements across pharmaceutical development, regulatory, quality, and supply chain.
Gene therapy preclinical, CMC, and regulatory strategy
Commercial Supply Chain Planning
Commercial supply chain for US launch of a blood cancer drug
Frequently Asked Questions
What types of CMC consulting does Alacrita provide?
+We cover the full CMC spectrum: pharmaceutical development strategy, CMC regulatory support for IND/NDA/BLA submissions, quality management systems, cGXP compliance audits, CMC due diligence for transactions, supply chain strategy, and interim CMC leadership. Our consultants have experience across small molecules, biologics, cell therapies, gene therapies, peptides, and delivery platforms.
What modalities do your CMC consultants cover?
+Alacrita's CMC consultants include small molecule specialists in API development, formulation, and scale-up; biologics specialists with expertise in antibodies, ADCs, and protein therapeutics; and cell and gene therapy manufacturing specialists covering process development, analytical methods, and tech transfer. We match consultants to the specific modality and development stage of each project.
Can Alacrita provide an interim VP of CMC?
+Yes. For virtual and early-stage biotechs that need senior CMC leadership but aren't ready to hire full-time, we provide consultants who serve as Interim VP CMC. They typically set up initial CMC activities, establish quality systems, manage CDMO relationships, and help recruit internal teams. The arrangement is usually flexible and scaled to the company's needs.
How does Alacrita's consulting model work?
+Alacrita combines a senior core team with a curated group of specialist consultants who work directly for the firm. This gives access to deep CMC expertise across modalities and geographies, with delivery managed by Alacrita throughout. Projects range from a single consultant providing targeted support to broader groups when a program requires cross-functional expertise. More detail is available on our Our Model page.
Does Alacrita conduct CMC due diligence?
+Yes. We provide CMC due diligence for investors, acquirers, and pharmaceutical companies evaluating transactions. This typically includes technical review of CMC documentation, manufacturing risk assessment, facility audits (on-site or remote), and risk mitigation recommendations. CMC DD is often provided as part of a broader assessment alongside clinical and regulatory due diligence.
Does Alacrita provide supply chain consulting for commercial launch?
+Yes. Our supply chain consultants help design and implement commercial supply chains for US and EU launches. This can cover upstream and downstream logistics, distribution licensing, GDP requirements, serialization, packaging, inventory strategy, 3PL vendor selection, and integration with regulatory, tax, and legal structures.
Get in Touch
Tell us about your CMC requirements and we'll outline how we can help.