A practical client-focused Approach Towards management of Chemistry, Manufacturing & controls activities
Our CMC Management Services are tailor-made for virtual drug development companies that lack critical mass in organic, physical and/or analytical chemistry. Mostly working with late-stage preclinical and clinical stage Phase I-III companies, we achieve the best results executing CMC Programs as fully integrated members of our clients' drug development teams.


 

Development of CMC Strategy & CMC Action Plan

We assist companies in developing realistic, phase‑appropriate, and fully actionable CMC development plans for small‑molecule and peptide therapeutics. Our approach spans the entire CMC lifecycle—from early route selection and analytical strategy through process development, scale‑up, GMP manufacturing, quality oversight, and regulatory documentation.

Whether you are initiating first‑in‑human activities or preparing for late‑stage development, we integrate every element of drug substance and drug product CMC into a coherent, risk‑aware plan that aligns with your program’s scientific needs, regulatory expectations, and operational constraints.

 

Comprehensive CMC Project Management & Execution Services

Acting as the liaison between our clients and their CDMOs, we provide comprehensive CMC oversight and support. We implement and drive CMC Action Plans by organizing and leading weekly teleconferences, tracking project progress, and delivering clear, timely progress reports to our clients’ management teams.

Our project‑management role extends across the full CMC workstream. We coordinate activities between drug substance, drug product, analytical, and quality functions to ensure alignment, continuity, and on‑time execution. 

We strive to anticipate risks, flag emerging issues early, and help teams navigate technical, operational, and regulatory challenges before they impact timelines or budgets. 

 

Management of Drug Substance and Drug Product Development

This is our core expertise. We support a wide range of CMC activities, including formulation development (oral solid dosage forms, injectables, intranasal dry powders), the evaluation of manufacturing routes, establishment of specifications and control strategies, assessment and optimization of manufacturing processes, troubleshooting, scale‑up planning, risk analysis, and oversight of clinical trial material (CTM) production.

Our services also include vendor selection and qualification, product and impurity characterization, stability study monitoring, analytical method development, and interpretation of analytical data. See also our Technical CMC Support Services.

 

QA Agreements, Master Service Agreements, SOW

Paperwork matters—and the details matter even more. We help ensure you start your vendor relationships on solid footing, reducing the risk of avoidable scope changes, cost overruns, and unwelcome surprises.

While we do not provide legal advice, we review Quality Agreements, MSAs, and Statements of Work from a CMC perspective to confirm that contractual terms, project scopes, and deliverables are fully aligned with your overall CMC strategy.