Our services
Comprehensive pharmaceutical solutions
Tailored to ensure operational excellence and regulatory compliance, from facility concept to product registration and reliable supply.
Turnkey project solutions
Complete facilities, delivered by one accountable team
We provide complete turnkey solutions for advanced facilities that aim for the highest level of GMP compliance. Our end-to-end expertise covers:
- Pharmaceutical manufacturing facilities
- Biopharmaceutical and vaccine (human and animal) facilities
- Research and development centres
- Quality control laboratories: microbiology and analytical
- LIMS, BMR and eQMS integrations
Scope of turnkey services
GMP-compliant facility concept & detailed design
End-to-end concept and detailed design for pharmaceutical and biopharmaceutical manufacturing, aligned with EU GMP, US FDA and WHO. Proper zoning, contamination control and inspection readiness are built in from the start.
Regulatory-aligned layout & process flow design
Facility layouts based on unidirectional flows for personnel, materials and waste. Regulatory expectations (Annex 1, Annex 15, WHO) are integrated directly into the layout to minimise contamination risk and ensure auditable environments.
Cleanroom design, execution & qualification
Pharmaceutical cleanrooms meeting GMP and ISO classification: concept development, detailed engineering, execution coordination, full qualification, airflow management and pressure differential optimisation.
HVAC & utility systems
Comprehensive HVAC design, installation and validation, together with critical utilities such as purified water, WFI, clean steam and process gases, optimised for robust operational compliance.
Equipment selection, installation & commissioning
Support in defining user requirements, selecting vendors, procurement and overseeing installation, so that every piece of equipment is fit for purpose and compliant from day one.
Software & automation integration
Integration and validation of BMS, EMS, LIMS and QMS. We ensure data integrity, compliance with Annex 11 and 21 CFR Part 11, secure system architecture and seamless operational integration.
Qualification & validation (DQ, IQ, OQ, PQ)
The complete qualification lifecycle, from Validation Master Plan development to PQ execution, using a risk-based approach so systems and processes perform as intended.
Regulatory inspection readiness & support
Gap assessments, mock audits, documentation reviews, staff training and on-site support to prepare facilities and teams for successful regulatory inspections.
Consultancy services & solutions
Specialist support at every stage
Engage us for a single workstream or combine several into a programme managed by one team.
01
Regulatory services
Registration and lifecycle management for products entering or already on the market, with a compliance strategy that anticipates regulator expectations.
- New product registration
- Renewal of existing product licences
- Post-approval variations and lifecycle management
- Artwork management and packaging compliance
- Regulatory gap assessment and compliance strategy
- Dossier preparation and submission support
02
Quality consulting & GMP support
Hands-on support to build, strengthen and demonstrate a quality system that stands up to audits and inspections.
- Vendor qualification, audit planning and execution
- Inspection and audit readiness, mock audits
- Documentation review and front-line staff training
- Sterility assurance and contamination control strategy (CCS)
- Deviation, CAPA and change control frameworks
- Quality metrics and management review
03
Learning & development
Training programmes that turn regulatory requirements into daily practice for operators, supervisors and quality teams.
- GMP training programmes, from basic to advanced
- Aseptic techniques and contamination control
- Regulatory inspection preparedness
- Data integrity and good documentation practice
- Customised on-site and virtual training modules
- Competency assessment and training records
04
Facility setup & renovation
Engineering support for new fit-outs and for bringing existing facilities up to current GMP and ISO expectations.
- Cleanroom consultancy (ISO and GMP compliance)
- Facility modernisation and renovation execution
- Equipment calibration and qualification
- HVAC excellence: temperature, humidity and pressure control
- Critical utilities: PW, WFI, clean steam, process gases
- Environmental monitoring programme design
05
Specialist services
Focused expertise for biotechnology products and the critical processes around them.
Biotechnology products
Process optimisation tailored to advanced biologics manufacturing and scalability.
Filter validation services
Robust testing and validation of critical filtration systems within sterile environments.
Technology transfer
Specialised input on transferring biotechnology products and processes efficiently and compliantly between sites.
Bioequivalence (BE) studies support
Support for bioequivalence studies to ensure regulatory acceptance across submissions.
06
Quality software solutions
Selection, implementation and validation of the digital systems that underpin a modern, data-integrity-compliant quality operation.
- eQMS: electronic quality management system
- LIMS and electronic batch records (e-BR)
- DMS: document management system
- TMS: training management system
- Computerised system validation (Annex 11, 21 CFR Part 11)
- Data integrity assessments and remediation
07
Strategic sourcing & supply chain
Compliant, reliable and cost-effective supply of the materials your products depend on.
- Identification of reliable, reputable suppliers
- Distribution agreements for APIs and excipients
- Supply chain vendor qualification and audits
- Supplier documentation and change management
- Cost and lead-time benchmarking
- Compliant, reliable and cost-effective supply
Not sure where to start?
Tell us about your facility, product or compliance challenge and we will propose the right scope and engagement model.