Engineering Solutions for Better Patient Care
Providing innovative engineering and project management solutions for the pharmaceutical industry worldwide
Engineering Consulting for the Pharmaceutical Industry
Biologics Manufacturing
Our team provides innovative solutions for the cGMP Manufacturing and Development of Biologics products for Mammalian Cell Culture, Microbial, aGene Therapy processes within the R&D and Commercial supply areas.
Oral Solids Drug Products Manufacturing
We provide a design and design implementation services for all aspects of the Oral Solid dosage formulations that includes integration of high containment equipment with OSD unit operations.
Chemical API Manufacturing
We offer process and project engineering services for the Chemical API Pilot Plant and Commercial Manufacturing in areas of chemical processing, highly toxic materials containment, and cGMP and Process Safety related solutions.
Utilities and Supports
Our team supports project execution in the areas of Clean and Plant Utilities and Process Support systems (e.g. Storage facilities, CIP/SIP, Waste collection and waste processing).
Sterile Drug Product Manufacturing
Our teams collaborate with clients on engineering design of the Sterile Drug Product Facilities addressing the product formulations, fill and finish, as well as component preparation integration.
Project Engineering and Management
Our Project Engineering and Management services help clients deliver projects on time, within budget, and to the highest standards of quality related to cGMP and Safety. We have a proven track record of managing and executing the projects of different TICs from $50K USD to $10M USD.
About Redwood Consulting Group
Our Vision
At Redwood Consulting, we envision a world where engineering solutions are sustainable, innovative, and accessible to all. Our goal is to lead the way in creating a better future through engineering excellence.
Our Services
We offer a wide range of engineering services including design, analysis, project management, commissioning, qualification, and training. Our team has expertise in various branches of pharmaceutical and biotech industries as well as fine and specialty chemicals.
Our Approach
We believe in a collaborative and client-focused approach to engineering and managing projects. By working closely with our clients, we are able to understand their needs and deliver solutions that exceed their expectations.
Expert Engineering Solutions
Process and Equipment Engineering
Our process engineers have expertise in designing facilities, equipment, process support and utility/waste systems that are efficient, compliant, reliable, and safe. We work with clients to understand their requirements and propose optimal solutions to meet their needs.
Project Management and Project Engineering
We provide project management services to ensure that engineering projects are completed on time, within budget, and to the required quality and safety standards. Our team has experience managing projects of various sizes and complexities.
Commissioning and Qualification Services
We offer commissioning, qualification and Validation (CQV) services to prepare and execute facility and equipment start-up for GMP and non-GMP systems. Our team of experts is well-versed in the latest requirements and can provide effective solutions that will streamline CQV.
Consulting Services
We offer consulting services to clients in Pharmaceutical and Chemical industries to help them optimize their engineering processes and operations. Our experts provide valuable insights and recommendations to enhance productivity, reliability, and reduce costs.
cGMP Compliance Analysis
Our structural engineers provide design and analysis services for various structures. We use state-of-the-art software and tools to ensure that our designs are safe, efficient, and comply with all relevant codes and standards.
Training and Education
We provide training and education services to help clients improve the skills and knowledge of their engineering staff. Our training programs are tailored to meet the specific needs of each client and cover a wide range of topics.
Recent Projects
A sampling of the projects we’ve worked on recently
Confidential Client
High Containment Modular Development Lab
GMP compliant Buffer Prep area
Cell & Gene Therapy R&D manufacturing pilot plant
Vaccine Adjuvant pilot plant development
ANNEX 1 GMP compliant parenteral Raw Materials sampling and dispensing area
Confidential Client
Sterile Fill & Finish GMP vial and syringe filling lines
Replacement of the original DCS control system with Emerson Delta V for 10,000 I/O system
Our Clients
Frequently Asked Questions
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The timeline for completing a project varies depending on the size and complexity of the project. We work with our clients to establish realistic timelines and ensure that projects are completed on time. These are the approximate project phases that are essential to the execution:
Project Charter Phase - Projects start with aligning the project and business drivers within the Project Charter. The charter is typically approved by the company's management.
Project Feasibility Study - In this phase the evaluation of project fit to the available facility, equipment, utility/services are performed. Is the project feasible and reflects drivers in the Project Charter. Usually, this phase is supported by the milestone schedule and Order of Magnitude Estimate. The leading option is proposed.Concept Design and Scope Development Phase - In this phase, the leading option is approved by the management and the scope equipment and associated facilities is determined. Frequently, it will be necessary to have pre-spend funds that will purchase number of Long Lead Equipment. The project cost estimate should be approximately 30% accurate, and the schedule is expended to contain major sub-step activities. After this stage the design is approximately 10% complete.
Basic / Schematic Design Phase - In this phase, the major items of design that requires process details, key specifications, critical facility / utility features are defined. All of the equipment is normally sized and specified. The design is at approximately 30% completion, and the budget is close to 10% accurate. The schedule activities expand to include major details of engineering, construction, commissioning and qualification, and procurement. Typically, the project funding is fully approved to move into the implementation of the project going forward at the end of this phase.
Detailed Design / Construction Documents Phase - In this phase, even the minor aspects of the design are finalized. Certified design drawings are prepared. Pre-construction phase is going forward (with permitting plans, construction execution details, construction safety requirements, sub-contract award plans, etc.). At this stage, the project schedule must be completely integrated, and pre-construction estimate defined.
Construction Execution Phase - This is where facility is constructed in accordance to the integration schedule and budget requirements. This phase may be implemented by the Construction Manager (CM) or a General Contractor (GC) depending on the project complexity and scope. Generally, the purchased Equipment is tested at the vendor and delivered on-site (or 3rd party location) and installed. At the end of this phase the CM/GC typically hand-over the Mechanical Completion of the Equipment / Facilities to the Commissioning. Any queries and issues are resolved with the Engineer of Record.
Commissioning Execution Phase - In this phase, the equipment systems and facility systems are started up by going through a static verification step, and the dynamic start-up steps. This step is absolutely essential to ensure that the design aspects of the project are reflected, and systems operate within safe limits and as intended.
Qualification Execution Phase - In this phase, the critical GMP equipment and facilities (e.g. HVAC, process gases) are validated as required for the pharmaceutical facilities. It is required to conduct the Installation and Operational qualifications of GMP systems, and follow up with the Performance Qualifications where required performance will be assured to be reproducible. Qualifications are typically done through the appropriate protocols.
Validation Execution Phase - At times, it is necessary to validate specific requirements for process, cleaning, and environmental monitoring to ensure that the equipment and facility is validated to deliver on the critical aspects and meet critical process parameters. After this phase, the Equipment / Process and Facility are turned over to the Stakeholders and released for the GMP use.
Project Close Out Phase - This phase is to ensure that all project required documentation, deliverables are closed out and turned-over to the clients within reasonable time.
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We work with a variety of clients including Commercial and R&D Manufacturing, Process Biologics and Chemical Development, GMP Operations and Development groups, Building Utilities and Supports.
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