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Process & Equipment Engineering Design

We provide comprehensive process and equipment engineering design solutions for pharmaceutical and biotech
production, ensuring efficiency, scalability, and regulatory compliance. Our services include the development of
critical design documents such as User Requirement Specifications (URS), Functional Requirement Specifications
(FRS), Process Flow Diagrams (PFD), Piping and Instrumentation Diagrams (P&ID), equipment specifications, and
other design required documents.

Upstream

Design and optimization of fermentation and cell culture processes for biologics production,
including bioreactor design, media preparation, and process integration.

Downstream

Development of purification and filtration processes to ensure high-yield and high-purity
biopharmaceutical products, supported by tailored equipment specifications and process control strategies.

Fill & Finish

Design and integration of aseptic filling, lyophilization, and packaging systems for final
drug products, ensuring compliance with cGMP and regulatory standards.

Supporting Functions

Incorporation of auxiliary systems such as buffer/media prep, parts washers,
autoclaves, and component preparation.

Facilities & Utilities Design

Our expertise in facility and utility design ensures compliance with cGMP regulations while maximizing operational
efficiency

Concept Design

High-level facility layouts and process flow diagrams tailored to project needs.

Basis of Design

Defining key project requirements, including regulatory, operational, and technical
specifications.

Detailed Engineering Design

Development of construction-ready documents covering all disciplines.

Value Engineering

Cost-effective design solutions without compromising quality, functionality, or
compliance.

Digital & Automation Design

We implement cutting-edge digital and automation solutions to enhance manufacturing efficiency, compliance, and
data integrity.

Process Automation & Control Systems

Integration of PLC, SCADA, and DCS for automated process
control and monitoring.

Manufacturing Execution System (MES)

Real-time production tracking, batch record management, and
quality assurance.

Asset Management System (CMMS)

Implementation of computerized maintenance management
systems for equipment reliability.

Building Automation System (BAS)

Smart facility management for HVAC, lighting, security, and
environmental controls.

Owner’s Representative

We act as an extension of your team, providing expert guidance to ensure projects meet quality, budget, and timeline
objectives.

Design Assist Services

Providing technical expertise during the design phase to optimize constructability
and compliance.

Site Master Planning / Technical and Business Case Analysis

Developing long-term facility strategies
and investment feasibility studies.

Oversight on Project Delivery

Ensuring alignment between design, construction, and operational
requirements.

Technical Peer Review

Independent evaluations of project designs to mitigate risks and optimize
performance.

Project / Construction Management

We manage complex projects with a focus on risk mitigation, cost control, and regulatory compliance to ensure
seamless project execution.

Project & Risk Management

Identifying and mitigating potential risks to keep projects on track.

Estimation & Project Control

Budget forecasting, cost tracking, and schedule management for optimized
project delivery.

Constructability Review

Evaluating design feasibility and construction efficiency to prevent costly
changes.

Construction Admin

Overseeing documentation, contract compliance, and quality assurance during
construction.

Engineering Services

Our engineering services ensure facility and equipment reliability, sustainability, and compliance with industry best
practices.

Risk Assessments

Conducting FMEA, HAZOP studies, and other risk evaluation methodologies to ensure compliance, safety, and process reliability in biotech manufacturing.

Calibration & Preventative Maintenance Program

Developing and implementing calibration and maintenance strategies to optimize equipment performance, minimize downtime, and ensure regulatory compliance.

Sustainability

Integrating energy-efficient and environmentally responsible solutions into biotech
facilities.

Tech Transfer and Scale-up Support

Assisting in the seamless transition of processes from R&D to fullscale manufacturing.

Commissioning, Qualification, & Validation (CQV)

We ensure biotech facilities and equipment meet regulatory standards through rigorous CQV programs.

Validation Master Plan

Comprehensive strategy outlining validation scope, protocols, and regulatory
requirements.

Equipment, Facilities & Utility C&Q

Commissioning and qualification (C&Q) of critical systems to meet regulatory and operational requirements for biotech and pharma manufacturing.

Performance Qualification

Verifying that systems, utilities, and equipment perform consistently within defined operational parameters to ensure product quality and compliance.

Cleaning & Process Validation

Establishing robust cleaning and process validation strategies to maintain product integrity, regulatory adherence, contamination control, and meeting quality attribute.

Compliance & Training

We provide regulatory compliance support and workforce training to meet stringent biotech industry standards.

Audits (FDA, Health Canada, EMA, etc)

Preparing for and conducting regulatory inspections and
compliance assessments.

Data Integrity & GMP Gap Assessment

Identifying and implement mitigation and corrective actions.

Change Management

Implementing structured change control processes to maintain compliance during
any change process.

SOP Creation & Training

Developing and delivering customized Standard Operating Procedures
(SOPs) and training programs for personnel.

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