Accelerating
Next Generation Therapies
to Patients

GxP System Integration & Delivery Services

cGMPnow Provides Turn-Key GMP Systems For

Next Generation Therapeutic Product Manufacturing

cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services using project-dedicated expert resources.

With our unique project delivery methodology and owner-focused involvement, we bring new products to the market faster by providing cGMP systems faster.

  • cGxP Specification Development (PRS, URS, FRS, DDS, etc.)

  • GMP ATMP Facility Conceptual Design / Feasibility Study

  • GMP Facility Architecture, MEP Detailed Design, Permit Drawings & Construction Support

  • Key Manufacturing & QC Laboratory Equipment In Place

  • Part 11 Compliant GxP Computerized Systems Hardware and Software in Place

  • Full Equipment, Facility & Computerized System Commissioning, Qualification and Validation

  • Autologous / Allogeneic Cell Therapy (CAR-T, NK, iPSC, IO, MSCs)

  • Viral vector platforms (AAV, RV, LV, HAV, OV)

  • pDNA, mRNA, LNP

  • mAbs, small molecules, ADCs, peptides

GMP Real Estate Services

cGMPnow accelerates Next Generation Therapies to patients by providing GMP Real Estate support services via our Real Estate Strategic Partner.

With our vast knowledge of potential GMP real estate and strategic partnership with the Vitrian (the leader in GMP Manufacturing development), we bring new products to the market faster by providing cGMP systems faster via a true END-TO-END solution.

  • Up-front Real Estate site selection and due diligence

  • Full GMP Facility Design / Build & Subsequent Leaseback

  • GMP MFG Facility "Make vs Buy" Assessments

GMP Compliance Services

cGMPnow accelerates Next Generation Therapies to patients by providing cGMP Compliance Services to ensure full regulatory compliance along the Therapeutic product development lifecycle.

With our vast knowledge of cGMP regulatory requirements (including Annex 1 SME) and industry best practices to drive phase-appropriate compliance, we bring new products to the market faster by providing timely and cost-effective cGMP compliance solutions.

  • Quality Systems and Compliance Support

  • Annex 1 Compliance Audits

  • Contamination Control Strategy program and document development

  • GMP MFG Facility Commercialization Readiness Support

  • Quality Audits (Internal/Mock Audits & External)

  • Supplier Quality Audits

  • GMP Training (Gowning, AP)

  • QA Staff Aug Support (Batch Record Review)

  • Periodic Requals: Temp mapping, EMPQs, APV, Airflow Visualization Studies, Disinfectant efficacy studies

  • Investigations/Root-cause Analysis/Deviations/CAPAs

  • CDMO Selection & CDMO Project Management

Accelerate Speed To Market

Faster Facility GxP Readiness

The cGMPnow streamlined approach to designing, procuring and qualifying cGxP-systems means your team can start production operations sooner

Greenfield? Brownfield? Existing Facility?

No problem!

The cGMPnow turn-key solution is efficient, scalable, and market-ready for any next gen therapeutic product

Products to patients faster

Dedicated project teams, comprised of industry experts, are committed full-time to delivering results

Fully Committed, GxP Experienced Resources Start-to-Finish!

Our project execution strategy drives the project from inception through CQV and turn-over.

Contact Us

We seek to improve lives.

We reduce your project timelines and bring the focus back to getting life-saving products to patients

How we conduct our business is equally as important as what we do

Our Core Values

Fully Committed, GxP Experienced Resources Start-to-Finish!

Why cGMPnow

The Problem

The standard industry GxP Systems delivery methodology for GxP MFG facilities is faced with the following issues:

  • The A&E/GC focus on the facility Design/Build with no focus on GxP systems

  • GxP Readiness is pushed to the Owner who typically does not have the bandwidth to handle it on top of day-to-day operations

  • The GxP MFG/Lab equipment, Computerized Systems, & CQV/GxP-documentation efforts are silo'd and disconnected

  • A&E/GC facility handover does not include adequate CQV or GxP documentation

  • Owner procurement systems cannot handle the quantity of GxP MFG and Laboratory Equipment that needs to be purchased associated with the project

  • GxP Systems are an afterthought and up-front facility designs do not adequately account for their needs

  • Facility Designs by the A&E do not keep pace with rapidly changing GxP regulatory requirements

The Solution

cGMPnow effectively delivers the GMP facility Architecture, MEP Detailed Design, Permit Drawings, Construction Support and GxP Systems for our clients to begin production, without time delays, design shortcomings and the typical project set-backs.  What does this mean to your team? We help accelerate life-changing products to patients