Symptome is a dynamic, startup-minded partner dedicated to life sciences.
Combining ‘Symptom’ and ‘Tome’ to identify project barriers and deliver efficient solutions
Project Delivery (Fixed Scope, Deliverable-Based)
Our Project Delivery service involves executing small to medium-scale capital projects with clearly defined scopes and deliverables. These projects are carried out by deploying subject matter expert (SME) consultants at client manufacturing sites, ensuring timely and high-quality execution. We assume accountability for deliverables and project outcomes.
Examples of Project Delivery Services:
- Engineering & Facility Expansion: Greenfield and brownfield projects, facility upgrades, and equipment installation.
- Quality Remediation: Addressing compliance gaps, regulatory findings, and CAPA implementation.
- Technology Transfer: Transferring processes between sites, scale-up support, and knowledge transfer.
- Process Validation & Qualification: Ensuring new processes meet regulatory standards before commercial production.
- Regulatory Readiness & Inspection Support: Preparing facilities for FDA, EMA, and GMP inspections.
- Automation & Digitalisation Projects: Implementing MES, QMS, and data integrity solutions.
Consulting Services (Time & Materials, Advisory-Based)
Our Consulting service provides expert advisory support across various technical and compliance domains. Unlike Project Delivery, consulting engagements are time-and-materials-based, meaning we provide expertise without liability for specific deliverables. This flexible service is ideal for clients requiring ongoing support and strategic insights without a fixed project structure.
Examples of Consulting Services:
- Regulatory Compliance & Audit Preparation: Advising on FDA, EMA, GMP, and ISO standards.
- Process Optimisation & Continuous Improvement: Identifying efficiency gains in manufacturing and quality operations.
- CMC (Chemistry, Manufacturing & Controls) Consulting: Providing guidance on regulatory submissions and product lifecycle management.
- Supplier & Vendor Auditing: Ensuring supply chain integrity and compliance.
- Training & Capability Building: Upskilling client teams on technical and regulatory topics.
- Change Management & Organisational Development: Supporting transitions in technology, processes, and regulatory frameworks.
Staffing & Recruitment Services (Resource Augmentation)
Our Staffing & Recruitment service provides rapid deployment of skilled professionals to fill operational gaps in manufacturing, quality, and technical roles. This service is the most flexible and has the lowest governance level, with no accountability for project deliverables—our role is simply to supply qualified SME consultants or full-time employees (FTEs) to support ongoing operations or project needs.
Examples of Staffing & Recruitment Services:
- Production Support: Deploying operators, engineers, or quality personnel for routine manufacturing.
- Capital Project Staffing: Supplementing project teams with additional expertise on a temporary basis.
- Maintenance & Calibration: Deploying specialists for routine maintenance, calibration, and reliability engineering.
- Computerised Systems Validation (CSV): Staffing for QMS, LIMS, KNEAT, MasterControl, and other digital validation activities.
- Analytical & Laboratory Support: Providing resources for analytical method validation, instrument audits & calibration, environmental monitoring & temperature mapping, testing, and lab workflow & process optimisation.
We are a life sciences consulting firm specialising in project solutions, consulting and staffing
Focusing on the life sciences industry, we provide tailored project solutions, consulting, and recruitment services to enhance compliance, streamline regulatory processes, and drive operational efficiency. Our mission is to uphold the highest standards in service and talent across the entire drug development lifecycle.
Maxim Vlasenko
Co-Founder at Symptóme | AI Advocate | Expert in Medical Affairs, Clinical Development & Commercial
Art Smirnov
Co-Founder at Symptóme | Project Delivery | Expert in Engineering, Technical Operations, Quality Assurance & Commercial
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