Put your consulting projects in the hands of qualified third-party experts. Outsourced project-based 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.
Need an outsourced project partner you can rely on? We draw on a large pool of the industry's best talent to help life science companies execute projects from start to finish with dedicated account management each step of the way.
Unlock cost efficiencies while utilizing the expertise of the industry's top specialists. Our 95% client success rate and 97% client satisfaction rate speak for themselves. We ensure you get the knowledge and expertise you need so you can focus on the future.
Our services are backed by a Total Quality Guarantee.
Access to outsourced resources accelerates the completion of project tasks.
Cut overhead and secure competitive rates.
Lift the constraints of an internal team to utilize skills and competencies from experienced third-party professionals.
Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidances, and best practices related to quality system management throughout the regulated life science industries.
GxP Audits (GMP, GLP, GCP, etc.)
QMS Process & Procedure Development
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.
Non-Conformance/Deviation Investigation Management Support
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 Responses & Remediation
PAI & Inspection Readiness
Internal Audit & Remediation Services
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.
Our resources can evaluate and enhance any link in your manufacturing operations from material receipt to finished product distribution.
Product & Personnel Controls
Packaging & Labeling
Our staff of engineering resources span multiple disciplines to ensure your needs are met. Whether you need to implement a global document control system or develop a package for your product we have the expertise to assist you.
Product, Process, and Equipment Engineering
Our resources can be utilized to meet the wide range of project requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.
Please contact us to learn more about fulfilling project needs. We help clients secure a wide variety of life science resources for project-based engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.