Chemistry, Manufacturing, and Controls (CMC) for Effective Drug Development
Pharmaceutical development and CMC aim to ensure that the medicinal drug is delivered to the right place, at the right time, and in the right amount every time it is administered to a patient.
Our experts help to ensure that your drug substance reaches the right place in the body, in the right amount and at the right time, to exert its optimal pharmacological effect.
Building a strong CMC strategy
In-depth knowledge about your specific project, product development, and drug delivery is central to a successful CMC program. Our CMC experts help you define the manufacturing process, quality control, specifications and stability of your product, helping you to identify gaps and build a strong CMC strategy. We establish close collaboration with identified contract manufacturers to gain essential information about a product’s manufacturing, quality, and stability. We develop a thorough understanding of the unique features of the drug substance and the drug product necessary to build relevant regulatory documentation.
Comprehensive Development Support
Provide tailored advice on formulation, process, and analytical development to ensure optimal drug efficacy and stability.
Regulatory Guidance
Guide you through procurement, quality standards, and CMC documentation compilation necessary for clinical trial applications and market applications.
Partnership Facilitation
Identify and engage contract research and manufacturing organizations (CDMOs) tailored to your drug´s specific development and production needs.
Strategic Advisory Services
Expert support in scientific publications, advice meetings, and due diligence assessments to strategically advance your product’s market readiness.
Formulation Development Expertise Across All Clinical Trial Phases
Understanding substance properties—such as solubility, permeability, and stability—is crucial for all formulation development. These properties determine the feasible types of formulations and routes of administration.
Lifecycle formulation types:
Placebo: The Formulation Challenge Developers Forget
LINK Medical´s experts help ensure your clinical trial integrity through the development of sophisticated placebos that match the active product in form, color, taste, and texture. This may require the addition of specific excipients to maintain the trial’s blinding integrity. Placebo formulation demands detailed attention to dosage, route of administration, and sensory characteristics.
Helping You Navigate CMC Regulatory Guidelines and Authority Meetings
Staying within regulatory guidelines typically eliminates the need for discussions with regulatory authorities. However, deviations from these guidelines should be communicated to the authorities to avoid rejection of market applications. It is crucial to remember that the substance and product used in pivotal clinical studies must be representative of the final marketed product.