Time- and cost-effective product development and registration demand that CMC activities keep pace with the stage of development and that the risks are identified and mitigated. The characterization of NCEs, establishment of adequate and development phase-appropriate impurity controls and specifications, and management of the supply chain, clinical supply, and commercial material must be in sync with the state of the science, the stage of development, commercial goals and constraints, and applicable laws and regulations. We provide our clients with development strategies that drive the overall product development process to meet milestones in a cost effective manner.
SciLucent guides sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes. We have experience with small molecule and biotechnology products and the full range of dosage forms used in solid oral, inhalation, intranasal, topical, and parenteral administration.
Experienced management of these activities ensures the quality of the materials being produced and the reliability of the clinical and commercial supply chain as it moves from bench-top through scale-up. We have experience with small molecule and biotechnology processes, including expertise in critical areas such as viral clearance strategies, excipient compatibility studies, and scale-up management.
SciLucent can oversee the development analytical methodologies for use in the control of starting materials, drug substances, and drug products. This spans the full lifecycle of methodology including creation, optimization, transfer, and validation.
Due to the length of time required to conduct stability studies and obtain requisite data, stability program management requires diligent integrated planning and oversight. We are well versed in the regulatory requirements and statistical processes required to support commercially viable product expiry periods. This includes the ability to design stability studies, analyze results, and compile and effectively present the data.
Selecting and efficiently managing vendors that are reliable, as well as technically competent, is one of the best tools available for minimizing the time needed to develop and register a drug or healthcare product. Contract manufactures, laboratories, and suppliers require diligent oversight and management so as to prevent development delays and cost overruns and to ensure the quality of products and deliverables. We work with vendors and clients to identify appropriate and place the required management processes to minimize the risks and maximize the value that these service providers can produce.
Healthcare product manufactures need capable oversight and development of clinical and commercial supply chain logistics to ensure a continued supply of goods to the clinic and the market. We provide logistical oversight from the acquisition of raw materials acquisition at the beginning of the process through to kitting and delivery of clinical materials to trial sites for developmental programs and 3PL warehousing for commercial products.
As an investigational product moves closer to commercialization and final to market, the CMC information is collected, maintained, and updated for both the drug substance and drug product. We have prepared numerous successful CMC and quality sections of regulatory submissions including meeting packages, INDs and CMC Amendments, DMFs, NDAs, postapproval CMC Supplements, Canadian NDSs, European IMPDs and MAAs, and postapproval variations IMPDs.
SciLucent has managed operational Quality Assurance functions for biopharmaceutical companies in all stages of development, as well as commercial operations. We have provided management of quality investigations, deviations, out-of-specification testing, change control, commercial complaints, and batch record review and release. In addition, we have facilitated QA review of CMC documentation including manufacturing process development protocols and validation reports, product specifications, manufacturing master records, and test methods.
Efficient and well-designed quality systems and appropriate development-stage implementation ensure that the expectations of regulators, sponsors, and investors are met. Many companies have unique needs that are best managed using customized quality systems and standard operating procedures. We develop or review Quality Management Systems to ensure compliance for a company’s current stage of operation.
Proactive initial and routine evaluation of vendor cGMP compliance minimizes the risks of quality issues and supply chain disruptions. It also reduces the potential for health authority actions such as 483s, compliance observations, warning letters, market restrictions, consent decrees, etc. Preparing in advance for preapproval inspections demonstratively assists in the avoidance of surprises during the approval and launch process. We identify, remediate, and help to minimize the impact of compliance issues, which can cause costly stock out or delays in commercial approval.
When compliance issues are encountered, it is critical to rapidly identify and understand the root cause, develop an appropriate and sufficient corrective action plan, and effectively communicate with the involved parties. Missteps in the handling of potential recall situations or in responding to regulatory compliance observations can lead to increased scrutiny, supply chain disruption, delays in approvals, and the loss of confidence of patients, doctors and investors. We assist in the management of critical compliance situations and provide meaningful, sustainable remediation guidance.