Our Services

We provide expert support to biotech companies throughout the entire course of their R&D and cGMP capital projects, and Facilities & Engineering department establishment.  The needs of organizations change significantly based on the size and stage of the project; Our offerings span across the product and organization lifecycle and can flex based on changing demand.

Strategize

Strategic cGMP Consulting

• Provide expert consulting services to cGMP facility owners and developers, guiding them through the site selection process with tailored solutions that optimize project success and mitigate risks. • Develop project requirements and collaborate with end users, architects, engineers, and contractors to create a comprehensive Basis of Design (BOD) that meets project goals and regulatory standards. • Expertly create comprehensive capital project plans, schedules, and budgets that enable clients to achieve their goals on time and within budget. • We have established strategic relationships with city officials, permit expeditors, and other key stakeholders to streamline the construction permitting process. • Leverage our network of experts, realtors, and real estate attorneys to help clients accelerate their property purchase timeline and improve lease negotiations. • Proficiently identify and mitigate potential risks throughout the project lifecycle, and efficiently manage change orders to ensure project success. • Specialize in negotiating and developing effective equipment procurement strategies, as well as selecting trade partners and negotiating contracts to meet project goals within quality demands, budgetary constraints, and schedule requirements.

Technical

Technical cGMP Engineering & Design

Technical Engineering

Ensure Quality and Compliance with Our cGMP Facility, mechanical, utilities, plumbing, electrical, IT systems and Automation Standards
Streamline Your Design and Maximize Efficiency with Our Experienced Review Team
Optimize Commissioning and Qualification with Our Expert Guidance
Maximize Project Success with Our Technical Collaboration and Expertise
Develop Facilities & Engineering organization.

Technical Documentation

Create Essential Documentation and Standards for Engineers and Facilities Operations
Develop Precise User Requirement Specifications (URS) for Seamless Facilities and Equipment Integration.
Develop a Standardized TOPs Process and Manage Historical Project Documents in Compliance with Part 11

Management

Capital Project Management

Capital Portfolio Management

Efficiently Manage Your Capital Projects with Our Customized Tools and Strategies
Deliver regular project status updates in accordance with client expectations.
Create a portfolio of planned future capital projects.
Develop a strategy for prioritizing future projects.
Establish a risk management framework that integrates risk assessment and mitigation into the capital project management process.

Cost & Schedule Controller

Help clients plan and budget for capital projects by providing detailed estimates of project schedules and costs.
Develop standardized Request for Proposal (RFP) comparison tools to facilitate project contract evaluations
Strategize RFP negotiation processes with vendors to ensure competitive pricing and favorable terms for project contracts.
Provide support for issuing purchase orders and service contracts, and tracking project costs throughout the lifecycle

EHS

Environment, Health & Safety (EHS)

EHS Responsibilities

To promote and maintain an injury-free workplace and environmentally sustainable operations in the communities in which we operate. We accomplish this by providing comprehensive workplace evaluation, emergency response, hazardous materials management, developing SOPs and safety policies, and managing regulatory requirements to ensure a healthy and safe workplace for ongoing research, development, and manufacturing of novel therapies.

EHS Function

Maintaining compliance with OSHA and other regulatory permits
Conducting risk assessments for high-risk activities
Performing ergonomic assessments of the workplace
Ensuring lab safety and chemical hygiene
Maintaining sustainability and recycling metrics and managing waste streams
Developing crisis management and incident communication plans
Implementing security governance and operational management

Maintenance

Facility Maintenance & Reliability Engineering

Facilities Operation

• Ensure compliance with safety, environmental, health, and fire regulations to prevent death, injury, or illness in the workplace.  • Ensure compliance with regulatory agencies by developing maintenance SOPs and providing necessary training to maintenance techs.  • Manage various site services, including pest control, landscaping, hospitality, GMP & non-GMP cleaning, waste management, and fire/life safety systems.  • Implement Computerized Maintenance Management System (CMMS)

Equipment Maintenance

• Support the implementation and management of sites Equipment Monitoring System (EMS) and Building Management System (BMS). • Maintain site assets through routine and non-routine maintenance repairs. • Oversee critical utilities maintenance and management. • Execute projects for site improvement, equipment upgrade/replacement, new equipment installation, and utility expansion

Metrology

• Develop a Global Metrology/Calibration Program with SOPs, forms, training, and calibration instrument life cycle management.  • Identify, procure, and maintain calibration standards and equipment.  • Establish GMP equipment/instrumentation Process Tolerance values and input them into the asset management system.  • Identify and onboard external calibration vendors and services.

Reliability Engineering

• Develop a Global Reliability Engineering Program that uses preventative maintenance, predictive technologies, and failure analysis to increase equipment availability.  • Consistently enhance equipment reliability through efficient maintenance management.  • Establish a Planning and Scheduling Program that incorporates work order screening, planning, and scheduling.  • Develop and manage maintenance spare parts for kitting and work order execution.

Qualification

Commissioning & Qualification

Facilities and Equipment Validation

• Collaborate with Quality, business process owners, and stakeholders to write the Global Validation SOP. • Write and annually update site Validation Master Plans (VMPs) and validation project plans for capital projects. • Establish and maintain ownership of the validation system document suite, including SIA, URS, protocol, and report. • Develop qualification and validation approaches that are phase-appropriate and minimize risks to patients and shareholders, while adhering to the QRM system framework.

Computer System Validation

• Develop the Global Computer System Lifecycle SOP in collaboration with IT and Quality to ensure compliance of GxP enterprise and site-based GMP systems. • Own and establish the complete CSV system document suite. • Provide strategic leadership for cost-effective and risk-minimized qualification of enterprise and site-based systems, focusing on function and leveraging IT configuration management. • Lead the implementation and enforcement of data integrity controls.

Turnover

Turn Over Packages (TOPs)

• Set up and hand over a centralized database where all turnover packages, warranties, and as-built drawings can be stored securely. • Deliver attic stock, list of spare parts and equipment operation manuals and training packages to operation team and end users. • Recommend and negotiate necessary maintenance contracts.

Regulatory Submission and Audits

• Collaborate with the Quality department and relevant stakeholders to ensure effective communication and coordination throughout the audit and FMEA processes. Seek input from subject matter experts to gain insights into specific areas of the facility and foster a collaborative approach to addressing quality issues and risks. • Support Regulatory team with regulatory submission and respond to various agencies’ (EU, FDA,...) questions.

WHY US

We Work Towards
Your Success

Empowering our clients with the technical expertise needed to build world-class biotech cGMP facilities that exceed regulatory and safety standards.

Proactive Management

We boast a proven track record of proactively anticipating challenges, streamlining processes, and spearheading innovation for exceptional project success.

Unwavering Quality

Our engineering consultancy consistently provides impeccable project execution, fostering client contentment and establishing unwavering trust

Innovative Solutions

Our consulting services excels in devising cutting-edge solutions, harnessing innovation for clients' unique challenges, and sustainable success.

Commitment to Safety

We uphold stringent company safety standards, ensuring a secure project environment through unwavering adherence to industry regulations.

Let's Make Your Vision a Reality

Reach out Today

CONTACT