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

We backfill key project management, construction, technical and engineering roles.

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

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:

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

Our experience includes QMS, policies and procedures for both ISO certification and global GMP compliance in addition to data integrity, audits, CMO management, regulatory, compliance remediation, QRAs and backfilling key roles.

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 are a versatile system integrator providing turnkey engineering services. We have subject matter expertise in small and large molecule facilities (including biologics and advanced therapies) and their equipment and technology.

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

Supply chain strategy​

ERP/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

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

Asset lifecycle management ​

Reliability and maintenance ​

Decommissioning ​

Training

Periodic requalification​

Performance metrics and KPI dashboards