Biomanufacturing
Strategy and Execution

Strategy

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

GMP Infrastructure Startup & Support

Manufacturing, Technical Operations Strategy

Make vs. Buy Business Case Analysis

Due Diligence

Program Management

Marketing

Finance & Project Controls

Talent Sourcing & Human Resources

Capital Projects, Tech Transfers and Facility Builds

We provide the following support for capital projects, tech transfers and facility builds. We also backfill key project management, construction, technical and engineering roles.

Program & Project Management

Facility Design

CMO / CRO Selection & Management

Vendor Selection & Management

Equipment Selection & Procurement

Infrastructure Support: Finance, Legal, IT & Marketing

Scope, Schedule & Budget Management

Backfill Key Technical Roles

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:

Traditional Commissioning & Qualification

Validation Program Development

Validation Maintenance

Process Validation

Computer Validation

Cleaning Validation

Steaming Validation

Laboratory Validation

Quality, Regulatory and Compliance

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 more.

Policies & Procedure Development

Quality Management Systems

Data Integrity (Part 11 compliance)

Auditing (CMOs, Vendors, Computer, IT)

CMO Management, Quality Agreements, PIP

NC & CAPA Program Development

Regulatory Submissions, Audits, Remediation

Quality Risk Assessments

Engineering, Automation and Serialization / Track & Trace

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.

Preliminary, Conceptual & Detailed Facility Design

URS, FS, DS

Equipment Design, Selection & Procurement

Vendor & Asset Management

Change Control Ownership

Part-11 Compliance

Facility Utilities: Mechanical, Electrical & Plumbing

System Owner & Process Engineering

Reliability, Maintenance and Asset Management

Our offering encompasses the complete asset management lifecycle starting with program and department creation. We can lead resource modeling and creation of policies and procedures, schedules, budgets, and operations to maximize production uptime.

Operations & Maintenance Staffing

Group Identification & Organizational Charts

Policies, Procedures & Training Materials

Asset Management Strategy

EAM & CMMS Selection

EAM & CMMS Optimization

Facility Gap Assessments & Optimization

Quality by Design Principals