Building Tomorrow’s Biologics Facilities

Building Tomorrow's Biologics

At RKDM's facilities, we design and maintain cutting-edge GMP biologics manufacturing plants tailored for the future.

Our Expertise

Our Promise

We combine deep industry knowledge with hands-on service to ensure your biologics facility runs smoothly and efficiently.

Our Services

Building and servicing next-gen GMP biologics manufacturing facilities tailored to your needs. The FDA does not build or certify facilities for you—instead, it regulates and inspects them.

Facility Build

Custom design and construction of GMP-compliant biologics manufacturing spaces from the ground up.

Ongoing Service

Comprehensive maintenance and support ensuring your biologics facility runs smoothly and efficiently.

The FDA does not build or certify facilities for you—instead, it regulates and inspects them.

We assist:

• Register the facility with FDA (Biologics Establishment Registration)

• List products manufactured (Product Listing)

• Renew annually

• FDA Approval of the Product (Not the Building)

Facility Registration:

• IND – Investigational New Drug (clinical trials)

• BLA – Biologics License Application (commercial approval)

We assist:

• Cleanroom classification (ISO 5–8)

• HVAC with HEPA filtration

• Pressure differentials (positive/negative)

• Material and personnel flow segregation

• Controlled access & security

We assist:

• Equipment & UtilitiesValidated • Filling lines

• Water for Injection (WFI)

• Clean Steam

• Compressed air/nitrogen

• Autoclaves