Life Sciences services
Every role between concept and compliance.
Quality, regulatory, clinical, R&D, validation, manufacturing, software and program leadership for medical device, pharmaceutical and biotech teams.
Our Life Sciences story, in six pages
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What we staff
Eight practice areas, each backed by consultants who have done the work in FDA- and ISO-governed environments. Open any category to see the specific skills.
Quality & Compliance
Quality systems that hold up to audits and inspections.
- Quality assurance, quality control and quality systems
- Quality remediation, gap assessment and investigations
- Risk management and design control
- CAPA and complaint handling
- Post-market surveillance
- Internal, external and supplier auditing
- Compliance engineering (US and international)
- Process development and engineering
Regulatory Affairs
Submissions and documentation across device, drug and software pathways.
- 510(k), 513(g), De Novo and Q-Sub / Pre-Sub
- PMAs, IDEs, INDs, NDAs, BLAs and CMC submissions
- EU MDR and IVDR, Clinical Evaluation Reports (CERs)
- Software as a Medical Device (SaMD) and Medical Mobile Apps
- SRS, SDS, architecture, traceability and hazard analysis
- Verification and validation documentation
- Breakthrough Device Designation, SPS and ACP
- Adverse event reporting, real-world performance monitoring and inspection readiness
Clinical & Medical Affairs
Clinical operations and medical writing from protocol to report.
- Clinical operations and clinical trial stages
- Medical writing and CER writing
- Medical affairs and medical monitoring
- Biometrics and bioinformatics
- Biocompatibility and toxicology
Research & Development
Product and process development from concept through lifecycle.
- Product development and design specification
- Analytical, method and process development
- Method validation and qualification
- Formulation and mRNA
- Total Product Lifecycle (TPLC) regulatory approach
Validation
Qualification and validation across facilities, systems and methods.
- Master Validation Plans and SOPs
- DQ, IQ, OQ and PQ
- Facilities, utilities, equipment, process and automation validation
- Computerized system, software and IT validation
- Test method, analytical method and laboratory validation
- Cleaning, sterilization, packaging and labeling validation
- Clinical and analytical validation
- Validation engineering documentation and execution
Manufacturing & Operations
Hands-on production, transfer and optimization support.
- Product assembly, packaging and labeling
- Sterilization and purification
- Technology and process transfer
- Process development and optimization
- Medical device manufacturer (MDM) and HDO support
Software, AI & Automation
Digital and automated systems inside regulated environments.
- AI model, AI product and AI device development
- Algorithm Change Protocols and SaMD Pre-Specifications
- Software design life cycle (IEC 62304)
- Automation engineering and controls
- Data selection, management and integrity
Program & Project Management
Leaders who keep regulated programs on schedule and on scope.
- Program and project managers for launches, remediations and transfers
- PMO support and cross-functional coordination
- Consent decree and warning letter remediation programs
- Capital project and facility start-up management
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