Extensive Pharmaceutical and Biotech Experience
At Riverside Resources LLC, our team brings 15-30 years of specialized experience in the pharmaceutical and biotech project management. We possess a thorough understanding of the stringent quality and regulatory requirements for cGMP facilities, allowing us to effectively manage critical systems and processes.
Key Areas of Expertise
- Utility Systems: Expertise in validated and non-validated systems such as RO, WFI, CIP, HVAC, and raw material delivery systems.
- Production Processes: Knowledge of biologic and pharmaceutical production, including sanitary piping, process vessels, aseptic and sterile filling, and complex equipment skids.
- Specialized Equipment: Experience with sterilization, lyophilization, chromatography, homogenization, centrifuges, filtration, and other advanced equipment.
- Facility Modifications: Skilled in overseeing new construction and modifications for production, laboratory, utility, warehouse, and office areas.
Project Execution
Riverside Resources LLC provides end-to-end support throughout all phases of capital project execution, including:
- Conceptual Design and Feasibility Studies: Assisting in initial project planning and evaluation.
- Scope and Schedule Development: Crafting detailed project scopes and timelines.
- Procurement and Construction: Managing the acquisition of materials and overseeing construction activities.
- Commissioning and Validation: Ensuring systems are operational and compliant with regulatory standards.
- Regulatory Submission: Preparing and managing submissions to meet regulatory requirements.
Tailored Services
We offer customized services based on your project requirements, including:
Defining and managing project scope and budget to prevent cost overruns and scope creep.
Creating realistic schedules to meet critical deadlines, such as production returns or product launches.
Identifying and managing potential bidders and vendors to ensure quality and adherence to schedule and budget.
Providing accurate and timely cost reports to monitor and control spending.
Ensuring safety through effective management of construction and field modifications using practices such as JSA, LO/TO, and hot work permits.
Developing and managing comprehensive project documentation, including drawings, specifications, submittals, and commissioning records.
Creating enhanced turnover packages to facilitate validation protocol development and execution.
Developing plans for robust system operation and reliable performance.
Coordinating validation and environmental monitoring activities in line with site or regulatory requirements.
Managing and updating Quality documents such as Change Controls, SOPs, and Batch Production Records.
Developing and executing programs to address production issues, increase capacity, or resolve quality and compliance concerns.
Find Out More
Do not hesitate to get in touch for an in-depth conversation about how Riverside Resources LLC can assist with your pharmaceutical or biotech projects.