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.
- Inc. 5000Fastest-growing private companies
- VOSBCertified Veteran-Owned Small Business
- 10,000+Vetted consultants in our network
- 75+ yearsCombined leadership experience in staffing
Our Life Sciences story, in six pages
Flip through the brochure here, present it full screen, or download it to share with your team.
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What we staff
Nine 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
- Design control and risk management (ISO 14971)
- CAPA and complaint handling
- Internal, external and supplier auditing
- Compliance engineering (US and international)
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
- Design verification documentation for submissions
- Breakthrough Device Designation, SPS and ACP
- Real-world performance monitoring and inspection readiness
Clinical Research & Medical Affairs
Trial operations, data and medical writing from protocol to report.
- Clinical Research Associates (CRAs) and clinical trial managers
- Clinical data management and biostatistics
- Clinical operations across trial phases
- Medical and scientific writing
- Medical affairs and medical monitoring
- Biometrics and bioinformatics
- Biocompatibility and toxicology
Pharmacovigilance & Drug Safety
Safety professionals who keep products compliant after approval.
- Adverse event case processing and follow-up
- Signal detection and benefit-risk evaluation
- Aggregate safety reporting (PSURs, PADERs, DSURs)
- Safety database management (Argus, ArisGlobal)
- Post-market surveillance and complaint trending
- Medical information and safety call support
Research & Development
Product and process development from concept through lifecycle.
- Product development and design specification
- Analytical and method development
- 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
- Analytical and clinical validation (SaMD)
- 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
How you can work with us
Four engagement models. Tell us the problem and we'll recommend the one that fits.
Contract
A consultant on our payroll for the length of your project. Weekly billing, no long-term commitment.
Contract-to-hire
Start on contract, convert to your team when it's working. Lower risk on both sides.
Direct hire
Permanent placements for roles you need to own, with the same screened network behind the search.
Project teams (SOW)
A small managed team for a defined scope, such as a validation package, a remediation effort or a facility start-up, under a statement of work with a single point of contact.
Where we place
Across North America. Headquartered in Beverly, Massachusetts, with team members in New York, Florida, Plymouth, Massachusetts and Japan, so we cover every U.S. time zone and then some.
- On-site, hybrid and fully remote assignments
- Travel assignments coordinated for consultants who go where the project is
- Local knowledge in the Boston and New England Life Sciences corridor
For employers
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