End-to-End Services
for the Entire Manufacturing Life Cycle

Due Diligence & Business Strategy

We can define and develop the strategy for our partners and also execute the strategy with confidence.

Due diligence technical assessments​

Landscape and market analysis​

Training and education​

Modeling (qualitative and quantitative)​

Capacity planning​

"Make vs. buy" or "build vs. buy"assessments​

Cost of goods analysis​

Facility build planning​

Owner's Representative, Project Management and SME Backfill

Our team can provide the resources you need and keep your project running efficiently from start to finish.

Program & project management​

Program development​

Drug developer owner's representation

Design build and construction firms​

Vendors or equipment suppliers​

CMO/CDMOs​

Project Management Office (PMO) creation and management​

Capital project management

Project Scheduling & Controls

Through comprehensive management and analysis of your project’s scope, cost, schedule, and risks, we ensure you have the requisite information to make informed decisions at every phase.

Project scheduling​

Cost controls​

Scope and risk management​

Production planning

CAPEX portfolio management​

Detailed schedule development​

Capital expenditure and facility projects​

Facilities optimization and process modeling​

Capital Project, Facility Builds & Tech Transfers

We manage and deliver complex end-to-end manufacturing solutions including manufacturing facilities, capital expansions, and technical operations.

Capital project planning and management​

Program and project management​

Facility design support​

CDMO selection and management​

Vendor selection and management​

Equipment selection and procurement​

Scope, schedule and budget management​

Technical transfer planning and management​

Commissioning, Qualification & Validation

We understand the different validation requirements for GMP, GLP, and GCP systems and various FDA, EMA, and other global regulations. We cover the gamut of validation services such as:

CQV planning and development​

Equipment, process, and cleaning validation​

Steaming validation

Computer system validation​

Laboratory equipment validation​

Environmental monitoring performance qualification​

Program development and maintenance​

Paperless validation implementation and support

Automation & Controls

Our offerings encompasses everything from system owner & process engineering ​to Manufacturing Execution System (MES) implementation​ and Paperless Batch Production Record system implementation.

Quality by Design & GAMP principles​

Preliminary, conceptual & detailed facility design (greenfield & brownfield)​

URS / FS / DS documentation​

Vendor and equipment selection, procurement and management ​

Change control ownership ​

Automation and integration​

Part-11 compliance ​

Facility utilities: mechanical, electrical & plumbing ​

Quality, Regulatory & Compliance

We ensure your project is compliant through policies and procedures ("SOPs") development , Quality management systems implementation (e.g.EMS, LMS, EAM, CMMS)​, auditing services​, compliance remediation, and more.

Supplier quality management program implementation​

Data integrity and Part 11 compliance​

CMO/CDMO selection and management, ​ quality agreements, person in plant​

Quality risk assessments​

NC and CAPA program development​

Regulatory strategy and submissions​

Audit preparation and support​

Health authority inspection readiness

Supply Chain

Whether it’s establishing your network strategy including internal and external capacity, or enterprise resource planning, our team can accelerate the development of your supply chain to maximize patient access.

Supply chain strategy​

ERP system implementation​

MRP system implementation​

MRP master data development andoptimization​

Capacity and long-term planning​

cGMP warehouse validation​

Operational readiness​

Cold chain and ultra-cold chain compliance

Operational Readiness

Our team is here to help ensure project execution, ensuring all components are prepared for seamless operations.

Computerized Maintenance Management System (CMMS) implementation​

Batch production record development​

Spare parts determination​

Staffing model development and staff augmentation​

Training documentation development​

Finite scheduling

calibration/preventative maintenance procedure development

policies and procedures development

Asset Lifecycle Management & Operations

Asset management strategy lays the groundwork for daily operations. We manage the plan to maintain critical assets and systems. For those looking to continuously improve their existing GMP facility, we can ensure your assets remain in a qualified state.

Environmental Health and Safety (EHS) program creation and evaluation​

Asset lifecycle management ​

Reliability and maintenance ​

Decommissioning ​

Training

Periodic requalification​

Performance metrics

KPI dashboards