We don’t spread ourselves thin across various industries. Instead, we focus on providing a deeper, richer bench of life science talent at the rate you need. Our large staff of internal resources and extended global network offer access to specialists wherever you need them.
We help thousands of firms, including 17 of the top 25 global pharmaceutical, biotech, and medical device companies, connect with the specialists they need, when and where they need them, through the optimal workforce model:
We'll work with you in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully develop due diligence strategies. Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.
Our experts prepare all major regulatory submissions and provide extensive quality control review for all trial-related documentation, such as:
Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:
Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.
Concerned your quality system doesn't reflect FDA expectations? Connect with former FDA and industry professionals who have extensive knowledge of FDA's current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.
GxP Audits
QMS Process & Procedure Development
Gap Assessments
QMS Remediation
Quality Unit Resourcing
Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.
Process Analysis & Enhancement
Investigation, Action Plan, & Effectiveness Check
Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.
Regulatory Observation/Warning Letter Responses & Remediation
PAI & Inspection Readiness
Internal Audit & Remediation Services
Demand for talented clinical operations professionals grows each day. How do you find the resource you need when you need them? Through years of connecting clinical operations experts with opportunities around the world, we’ve developed a large active, and extended pool of talented professionals.
We can fulfill clinical contracted and direct hire resource placement needs in a variety of roles and functions including, but not limited to:
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Hire full-time consultants, on contract, for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, test-run your job descriptions, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
Our services are backed by a Total Quality Guarantee. If for any reason, you are dissatisfied with any service, we will provide you with a full refund.