At Pace® Life Sciences, our understanding of global pharmaceutical operations and regulatory challenges facing these industries; allows our experts to provide comprehensive support across the drug development pipeline.
From early strategy discussions and meetings with agencies to submissions and applications support on through commercialization, we help our clients with regulatory, compliance, validations, training, and auditing support.
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Early-Phase Consulting
Regulatory Strategy
Leverage our expertise in R&D and early-stage development.
- Drugs, biologics, gene therapies, drug-device combination products, and medical devices
- US, Canada, EU, Asia, and rest of world
Guidance on Pathways
Determine your path forward with insight provided by our consultants. We provide insight on:
- Expedited pathways
- Project management of cross-functional teams for Investigational New Drug (IND) development
Support with Agency
Our consultants are here to offer guidance in meetings with US, EU, and international regulators. We can provide guidance on strategy, process and submission packages, and support formal meetings, such as Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products:
- Formal Meetings with FDA, Type B
- Pre-IND discussions
- End of Phase 2 (EOP2) support
- Pre-NDA / Pre-BLA
- Formal Meetings with FDA, Type C
Authoring
Ensuring your application or submission represents your work accurately and thoroughly often requires an extra set of eyes. Our consultants can support:
- Technical authoring or review of regulatory submissions
- Orphan drug applications
Late-Phase Commercialization Consulting
Compliance Strategy
Successful compliance requires knowledge of the current regulatory environment, effective quality assurance, and risk management. Our services include:
- Assessing existing quality systems
- Conducting risk assessments
- Developing effective, ‘right-sized’ compliance programs and quality systems
- Ensuring best practices in cGMP, GLP, GTP, ISO, CLIA
- Training programs for compliance and CAPA
- Remediating audit or inspection findings
Master Planning
Effective validation master plans should align expectations, improve budgeting, and inform project management. Our experts can help develop a plan to:
- Control cost and schedule
- Coordinate commissioning, qualification, and validation activities
- Ensure best practices
- Meet regulatory requirements
Validation
Full compliance with regulatory requirements is the cornerstone of successful product development. From Factory Acceptance Test (FAT) support to high-level validation approaches to detailed on-site services, our team support:
- Facility and utility systems validation
- Process equipment validation
- Analytical equipment validation
- Computer systems validation
- Manufacturing processes validation
Contract Services
Auditing
Our professionals help in demonstrating and maintaining compliance through credible audits. These services span:
- Third-party audits/supplier selection audits
- Benchmarking and gap analysis
- Quality improvement
- Regulatory inspection readiness
- Critical phase inspections for GLP
- Supplier selection and monitoring
QA & Compliance Training
Develop and promote employee behavior that aligns regulatory requirements with business goals through our training offerings, which include:
- Training for GXP compliance
- Quality assurance strategies
- Report-writing, deviation-reporting, and root cause workshops