Full CMC Pharmaceutical Development Services
Our Chemistry, Manufacturing and Controls Expertise
Pharmaceutical drug product development requires knowledge and expertise in formulation, manufacturing, and process engineering. Our Chemistry, Manufacturing and Controls (CMC) team is comprised of highly skilled formulation experts and process engineers, PhD scientists and professionals having varied experience across different technologies, dosage forms and therapeutic areas.
PharmSky can provide support throughout the entire lifecycle of the product starting from early phase formulation design and development to manufacturing of clinical trial material (CTM) , analytical method development and testing and regulatory support including for the CMC parts of IND preparations for the US or to meet specific regional regulatory requirements.
PharmSky provides high quality, expedited development to meet key business milestones and complete critical CMC activities for pre-clinical, clinical and product registration phases.
Key CMC Pharmaceutical Development Services
Integrated CMC development services for complex drug products
PharmSky provides CMC pharmaceutical drug development support for innovators moving from early research into pre-clinical, clinical and registration-focused development. Our team brings formulation, analytical, process development, manufacturing and regulatory knowledge together, helping sponsors build a practical CMC pathway around the specific needs of their molecule, dosage form and target market.
Effective chemistry manufacturing and controls planning is critical to drug product development. It shapes how a product is formulated, manufactured, tested, controlled, documented and ultimately reviewed by regulators. PharmSky’s pharmaceutical CMC services are designed to support these requirements from the earliest feasibility work through to clinical trial material manufacture and CMC regulatory support.
Our CMC development services can include pharmaceutical formulation development, excipient selection, prototype screening, analytical method development, stability study design, pharmaceutical process development, clinical batch manufacture and preparation of technical data for regulatory submissions. By linking these activities within one development program, PharmSky helps reduce technical gaps, avoid unnecessary duplication and keep CMC drug development aligned with clinical and commercial objectives.
For sponsors that need targeted CMC consulting, PharmSky can provide stage-appropriate guidance on development strategy, manufacturing considerations, analytical requirements, regulatory expectations and risk management included with all our service packages. This is particularly valuable for complex formulations, injectables, nano liquid emulsions, topicals, oral liquids, solid oral dosage forms and differentiated generic products, where early technical decisions can materially affect later development outcomes.
With practical experience across drug product development, GMP manufacturing, analytical testing and regulatory compliance, PharmSky helps pharmaceutical and biotech companies progress with clarity. Our goal is to give each program the scientific discipline, technical documentation and development momentum needed to move confidently towards clinical trials and beyond.
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Frequently Asked Questions
In the pharmaceutical industry, CMC stands for Chemistry, Manufacturing, and Controls. It refers to the comprehensive set of activities and documentation that cover the development, production, and quality control of a pharmaceutical product. CMC is a critical part of the drug development process and plays a central role in ensuring that a drug is manufactured consistently, meets regulatory requirements, and is safe and effective for patients.
1. Chemistry: This involves the study of the chemical properties of the drug product, including APIs, excipients and the final dosage form (e.g., tablet, injection).
2. Manufacturing: This part includes the development and optimisation of the manufacturing processes for the final drug product. The process can be scaled up from laboratory or pilot scale to full-scale production while maintaining the compliance with regulatory standards for manufacturing, including cleanliness, equipment maintenance, personnel training, and environmental controls.
3. Controls: This includes the testing and validation of raw materials, intermediates, and final products to ensure they meet the required quality standards. Stability studies will be conducted to assess how the drug product holds up over time under different conditions (e.g., temperature, humidity, light) to determine its shelf life and proper storage conditions.
