Pharmaceutical consulting
Our pharmaceutical consultants are highly trained, motivated professionals.
We can provide project engineers, project managers, quality assurance and validation specialists, functional and business analysts. All our consultants, staff and freelance, receive proper coaching fit for their level of experience and the requirements of their assignment.
Our pharmaceutical consultants can be staffed in a traditional consultancy model, but we also offer integrated teams with the option of a fixed price model. We can also facilitate the growth of your internal staff through our academy model.
Managed services
Validation and quality assurance as-a-service
We have experience executing validation and quality assurance projects from beginning to end, we can propose a fixed-price solution for your needs in
- CSV
- Execution and documentation of equipment, facility validation (e.g. thermal mapping)
- QA document review
- Technical writing
- Quality risk assessments (e.g. FMEA)
- Project coordination
Or we can propose a fixed team of consultants to take care of your operational workload at an hourly, daily or monthly fee. We are ready to jump straight in to assist you with CSV, validation, quality assurance or complaint handling.
Auditing, audit readiness and remediation
We help you prepare for inspections, remediate audit findings or make sure suppliers are meeting your expectations.
We execute supplier audits, internal audits and assist your organization in audit preparation or remediation.
Supplier audits allow for a complete evaluation of the supplier organisation, quality system, technical capability and key practices.
A typical supplier can be audited in just two working days, as such benefits of conducting a supplier audit far outweigh costs.
An internal audit of your facility, service or quality system by a consultant can identify issues which would remain undiscovered when relying just on internal auditors.
We manage audits at your site in all discretion, in different fields of expertise.
We have experience setting up extensive audit remediation programs, for example after a warning letter.