Pharmaceutical & Nutraceutical Consulting Services
Nine capabilities, organised five ways. Manufacturing problems rarely arrive one at a time, so the list is grouped the way engagements actually run - find the part that applies to you.
Facility Setup & Regulatory Compliance
We plan and commission manufacturing facilities against current FDA cGMP guidelines - layout and flow, environmental controls, material and personnel segregation, and the documentation system that has to hold up under inspection. Corporate SOPs are written to your actual process, not adapted from a template. Work is led directly by a GMP Auditor, so compliance gaps get caught at the design stage rather than during your first audit.
Included capabilities
- 01Facility setup per FDA / cGMP guidelines
- 02Corporate SOP development
- 03Regulatory & GMP compliance consulting
- 04Audit readiness and gap assessment
Formulation Development
Solid dose formulation work covering tablets, capsules and powders - including blending and mixing, granulation and coating. We develop formulations that survive the transition from bench to production line, accounting for the equipment you actually run, the excipients you can actually source, and the label claims you need to hold. Scale-up parameters are documented so your batch records match reality.
Included capabilities
- 01Tablets, capsules and powders
- 02Solid dose formulation
- 03Blending & mixing
- 04Coating processes
- 05Bench-to-production scale-up
Equipment Solutions
End-to-end equipment support: sourcing and brokering both new and used machinery, installation and commissioning, in-process manufacturing equipment, and design and process validation. Once you are running, preventive maintenance schedules and troubleshooting keep lines qualified and uptime predictable. One point of contact from specification through the maintenance interval - not a different vendor for every stage.
Included capabilities
- 01Equipment installation & commissioning
- 02Equipment purchase & sell (sourcing / brokering)
- 03Manufacturing in-process equipment
- 04Equipment design & process validation
- 05Preventive maintenance & repairs
- 06Troubleshooting
Custom Packaging
Custom packaging solutions for finished product - matched to the dosage form, the shelf-life requirement, and the line speed you need to hit. We specify the format and the equipment together, so the packaging you commit to on the label is the packaging your line can actually run at volume.
Included capabilities
- 01Custom packaging solutions for finished product
- 02Format and material specification
- 03Packaging line compatibility review
New Business Development
For companies entering pharmaceutical or nutraceutical manufacturing, we work through the whole path: what product lines make sense, what equipment they require, what the facility and compliance burden looks like, and what it costs before you commit capital. Covers tablet, capsule, blending and mixing, and coating lines - with a realistic sequence for standing them up.
Included capabilities
- 01Market and product line assessment
- 02Tablet and capsule line planning
- 03Blending & mixing line planning
- 04Coating line planning
- 05Capital and compliance roadmap
How the work is structured
Assessment before specification, specification before capital. The order is what keeps a compliance project from becoming a redesign.
- 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.
Which of these does your operation actually need?
Most engagements start with a single problem and turn out to touch two or three of these areas. Describe the situation and we will scope it honestly.