Professional
Services
Break through operational challenges by partnering with our integrated teams focused on superior service and industry expertise.
Advance your program with tailored managed & professional services backed by decades of industry experience.
FDA eCTD Submissions: Compilation and Publishing
Making an electronic common technical document (eCTD)-compliant submission to the FDA requires complex coordination of stakeholders and a detailed culmination of…
Pace® Life Sciences Appoints Dawn Von Rohr as Division President
Von Rohr is an experienced leader with over 25 years of expertise in global CDMO strategic growth initiatives and operational improvements, specifically within the pharmaceutical industry.
Pace® Professional Services include scientific staffing and management, laboratory relocation, facility qualification and certification, instrument repair and maintenance, compliance and audits, hazard communication and product stewardship, and regulatory affairs consulting. Backed by decades of experience managing our own laboratories and facilities, we provide the expertise and capacity to maintain ongoing operations across functions and industries, and we know how to plug into your program gaps without the effort or lead time typically needed to keep progressing.
Professional Services to Maintain Compliant, Ongoing Operations.
INSOURCING SOLUTIONS
SCIENTIFIC STAFF
Your Challenges - Our Solutions,
Performance & Program Management
FACILITIES
FACILITIES
Validation Services,
Environmental Monitoring,
Lab Relocations
INSTRUMENTS
INSTRUMENTS
REGULATORY & COMPLIANCE SERVICES
REGULATORY & COMPLIANCE SERVICES
Support Specialized to Your Program
From start to finish, our full-service approach means you’ll have the scientific resources to meet your development and delivery goals — supported by our deep scientific knowledge and industry experience.
Add scientific power to your projects with Pace® Managed & Professional Services.
MEET
Meet with a Pace® professional to discuss your specific scientific requirements and project goals.
COLLABORATE
Collaborate with your dedicated Pace® professional to create a tailored, scalable solution.
PARTNER
Partner with your Pace® professional for ongoing communication, timing and progress tracking aligned with goal milestones as well as program adjustments and optimization.
Meet Key Industry Standards
ISO 9001:2015 Accredited Experts
Our ISO 9001:2015 accredited experts deliver the level of service, support, and ongoing product knowledge needed to keep your laboratory instruments in peak condition.
Cleanroom Certification
Our testing services comply with multiple industry standards, including Current Good Manufacturing Practices (cGMP), Institute of Environmental Sciences and Technologies (IEST), and International Organization for Standardization (ISO), USP <797>, USP <800> and USP <825>.
Environmental Monitoring Compliance
Our services start with consultation to determine your assessment needs. All our work is performed in strict compliance with current Good Manufacturing Practice (cGMP) requirements following USP, EP, JP, ISO, or client-specified standards.
Validation and Compliance
From FAT support to high-level validation approaches to detailed on-site services, our professionals can help with:
- Facility Systems Validation
- Process Equipment Validation
- Lab/Analytical Equipment Validation
- Computer Systems Validation
- Manufacturing Processes Validation
- Master Plans
- GXP, GMP, GLP, GCP, GCLP, GTP, ISO, CLIA
Product Stewardship
We effectively manage and meet product stewardship requirements by applying our extensive knowledge in chemistry and our multifaceted understanding of the current global regulations that chemical manufacturers must adhere to. Our teams have expertise in the following:
- California Prop 65
- EU REACH and ROHS
- TSCA
- Cleaning Product Right To Know Act (SB 258)
- Product Label Reviews for DOT Guidance, CPSC, CCCR, and GHS
- Canadian New Substance Notification
- Country-specific Inventory Checks (K-REACH, DSL & Non-DSL, CPSC, Country Specific Lists)
Hazard Communication
Ensure your workplace safety procedures meet Hazard Communication Standard (HCS) and Globally Harmonized System (GHS) requirements. Safety Data Sheets (SDSs) are essential for workplace and transport safety and are mandated by federal regulations. We also focus on database population, acquisition integration and dossier preparation for customer data requests.
FDA Regulatory Pathways
Maintain progress as your drug development program reaches pivotal regulatory stages by engaging our experts to identify, prepare, and submit the appropriate materials to regulators. Our regulatory affairs consulting services include:
- Orphan Drug Designation and Annual Reports (FDA and EMA)
- Rare Pediatric Disease Designation
- Regenerative Medicine Advanced Therapy Designation
- Qualified Infectious Disease Product Designation
- Fast Track Designation
- Breakthrough Therapy Designation
- Investigational New Drug Application (IND)
- Biologic License Application (BLA)
- New Drug Application (NDA)
- 505(b)(2) NDA Application
- eCTD Publishing
Who We Work With
Pace® Professional Services supports numerous industries, functions, and company sizes facing capacity or capability gaps. While our business started in the environmental industry, we established a strong foothold in life sciences in the early 2000s and provide long-standing services to numerous other fields. Whether you are performing research and laboratory operations, or manufacturing and exporting materials, partnering with us offers a customizable solution by professionals attuned to your unique needs, parameters, and regulations.
Delivering Premier Partnership
When you work with Pace®, we meet your needs as considerate partners rather than simply a service provider. By offering a consultative approach, we keep your priorities and restrictions in mind to identify the best path forward with aims to establish long-standing relationships that alleviate internal constraints. Our services deliver solutions suited to your unique circumstances and scale, paired with the necessary documentation and deliverables to meet your key objectives.
We honor our commitments so you can honor yours™. We
promise to deliver a level of quality that meets your data
quality objectives — supported by personal service, ethical
standards, data transparency, and the highest level of support
possible. This is the foundation of the Pace® Promise.
- RELIABLE DELIVERY
- COLLABORATIVE RELATIONSHIPS
- EXCEPTIONAL SERVICE
Keeping Pace® with Pharma
Discover unique insights to meet milestones, achieve regulatory compliance, and relieve internal constraints.
Why Laboratories Partner With Pace®
We promise to deliver a level of quality that meets your data quality objectives, supported by personal service, ethical standards, data transparency and the highest level of support possible.
Pace® is a community of scientists who are passionate about achieving your goals. We utilize more than 40 years of expertise in running labs to provide you with experienced professionals and services to support you and your scientific work. Working together to develop and innovate products, continuously improve — ultimately delivering science better.
Integrated Laboratory Services
Maintain compliant, ongoing operations with our array of talented teams. We have the people power to support drug development, perform central laboratory testing, and advance medical device projects.