GMP Auditor Led Pharmaceutical Consulting
In compliance consulting the credential is the product. What you are buying is judgement - someone who has assessed facilities against the standard and knows where the gaps actually appear. That is the whole basis of this practice.
Mohammed Z. Rahman
GMP Auditor · President
Mohammed Z. Rahman, GMP Auditor
Mohammed Z. Rahman is a certified GMP Auditor and the President of Ztech Consulting & Tech Inc. The practice covers the full arc of a manufacturing operation - facility setup and regulatory compliance, formulation development, equipment specification and installation, custom packaging, and support for companies entering the sector for the first time.
The work is deliberately hands-on. Facility layouts, equipment lists and SOPs are produced by the same person who will be on site during installation and commissioning - which means the design reflects how the line actually gets built, not how it looks on a drawing.
Because the auditor credential sits with the principal rather than a subcontractor, compliance exposure is assessed at the design stage. Problems get caught while they are still a drawing revision instead of a finding.
- Credential
- GMP Auditor
- Role
- President
- Based in
- Ronkonkoma, NY
- Verticals
- Pharmaceutical & nutraceutical
- Standard applied
- FDA cGMP guidelines
- Service disciplines
- Five, setup through maintenance
The gap between a general engineer and a regulatory specialist
Small and mid-size pharma and nutraceutical manufacturers sit in an awkward position. They are too small to carry a full internal compliance and engineering department, but the regulatory standard they are held to is identical to the one applied to companies a hundred times their size.
The usual options are both imperfect. A general engineering firm can build the facility but treats cGMP as an unfamiliar constraint. A large consultancy understands the regulation but prices the engagement for a different class of client and staffs it with rotating juniors.
Ztech Consulting & Tech Inc exists in the middle of that: specialist regulatory and manufacturing capability, delivered directly by the person who holds the credential, at a scale that fits a company standing up its first or second line.
Where the hands-on work sits
Three overlapping disciplines. Most engagements draw on all three, which is the point of keeping them in one practice.
Regulatory & audit
- FDA cGMP guideline interpretation
- Corporate SOP authoring
- Audit readiness and gap assessment
- Documentation systems
Formulation & process
- Solid dose formulation
- Blending, mixing and granulation
- Coating processes
- Bench-to-production scale-up
Facility & equipment
- Facility layout and flow design
- Equipment specification and sourcing
- Installation and commissioning
- Process validation and preventive maintenance
Certifications and standards
Held by the principal, applied on every engagement.
- 01GMP Auditor
- Certified auditor credential held by the principal consultant.
- 02GMP Certified
- Good Manufacturing Practice certification.
- 03FDA / cGMP
- Facility and process design to current FDA cGMP guidelines.
Four stages, one relationship
The sequence is the same whether the scope is a single equipment installation or a facility from empty shell to first validated batch.
- 01
Assessment
A direct review of where you are: existing facility, target product, regulatory exposure and the gap between them.
- 02
Specification
Facility layout, equipment list, formulation approach and SOP framework - documented with the capital cost attached.
- 03
Build & commission
Installation, qualification and process validation, with the documentation trail assembled as the work happens.
- 04
Sustained support
Preventive maintenance schedules, troubleshooting and audit support once the line is running.
Talk to the person who will actually do the work.
Every enquiry reaches the principal directly. No account manager, no discovery call before the technical conversation.