Drug Development Consulting Services
SCx CMC Solutions connects pharmaceutical and biotech companies with experienced consultants offering tailored drug development solutions for every phase, from preclinical to commercial.From regulatory challenges to operational strategy, our intentionally selected specialists deliver tailored solutions to keep your product on track and positioned for success.
Drug Modality Expertise
SCx has expertise in development of all synthetic modalities, including small molecules, peptides, oligonucleotides, drug conjugates, and biologics.
- Cell Line Development
- Mammalian & Microbial Expression and Manufacturing Peptides, Oligonucleotides, mRNA
- Cell & Gene Therapy
- Advanced Analytics
- Advanced therapies and combination products
Navigate Small Molecule and Biologic Complexity
API Drug Substance Services
SCx CMC consultants guide you through the regulatory and technical challenges of drug substance development. From high potency to sterile drug substances, we help ensure your active pharmaceutical ingredient (API) is on track.
- Regulatory Starting Materials Designation
- Phase-appropriate Drug Substance Specifications
- Mutagenic Impurities and Nitrosamines Control Strategy
- Registration Stability Batches
- Process Parameter Criticality Assessment and Commercial Process Validation
- Regulatory Submissions (US FDA, EMA, Japanese PMDA)
Controlling Impurities, Guiding Compliance
Dosage Form Expertise
Our drug development services include expertise in dosage from innovation, ensuring optimal formulation, performance, and patient experience–from traditional solids and liquids to advanced sterile injectables, devices, and complex delivery systems tailored to your product needs.
- Solid oral dosage forms
- Liquids creams and ointments
- Semi-solid forms and hydrogels
- Sterile injectables
- Specialty dosage forms (e.g., pulmonary delivery systems, transdermals)
- Drug/Device combination products
Formulation Pros for Complex Delivery
Drug Development Execution
Each dosage form presents unique challenges. Our consultants leverage core pharmaceutical development expertise in a flexible, stage-appropriate way to ensure your development aligns with regulatory, business goals, and budget considerations.
- Target product profile
- Dosage Form Selection and Design
- Product Development Strategy and Execution
Applied CMC Insight for Practical Progress
Discover Trusted Drug Expertise
SCx CMC Solutions transforms ideas into market-ready products, delivering high-impact CMC drug development guidance from concept through commercialization.