Pharmaceutical and Biotech
The staff of Riverside Resources typically has 15-30 years of experience in the pharmaceutical and biotech fields and has a strong understanding of the stringent quality and regulatory requirements for cGMP facilities. Our expertise includes:
- Validated and non-validated utility systems including RO, WFI, CIP, HVAC, raw material delivery systemsand most other critical systems typically found in pharmaceutical manufacturing and laboratory facilities
- Biologic and pharmaceutical production processes and equipment including sanitary piping and process vessels
- Aseptic and sterile filling
- Sterilization, lyophilization, chromatography, homogenization, centrifuges, filtration, and complex equipment skids
- Facility modifications and new construction for production, laboratory, utility, warehouse and office areas.
We have led or assisted in all phases of capital project execution from conceptual design and feasibility studies; to scope and schedule development; through procurement and construction; to commissioning, validation and regulatory submission by providing owner's representation, project management, project controls, construction management, project engineering and program management services to a variety of clients. Based on your needs, our field, operations, and management experience allows Riverside Resources to:
- Develop and manage a defined scope of work and budget to ensure your project remains on schedule and prevent cost overruns by minimizing scope creep and change orders.
- Develop and manage a realistic schedule to meet your return to production, regulatory submission or product launch target date.
- Identify potential bidders and vendors that meet your site or corporate requirements and manage the bid and procurement processes to maintain quality, schedule and budget.
- Provide timely and accurate cost reporting to monitor and manage spending.
- Ensure personnel and equipment safety by managing construction and field modifications using safe work practices and systems such as JSA, LO/TO and hot work permits.
- Develop and manage project documentation files such as drawings, specifications, submittals, installation, testing and commissioning records typically required for validated equipment and processes.
- Create enhanced turn-over documentation packages to expedite the development and execution of validation protocols.
- Develop and execute commissioning plans needed for the development of robust operating parameters and reliable systems operation.
- Define (based on your site or regulatory requirements) and coordinate any validation and/or environmental monitoring activities needed for return to production or regulatory submission.
- Identify (based on your site or corporate cGMP requirements) and coordinate documentation development or updates for Quality documents such as Change Controls, Standard Operating Procedures or Batch Production Records needed for each project phase.
- Manage or assist in the development or execution of remediation programs to address outstanding production or maintenance issues, increase production capacity or address quality or compliance concerns.