Confidently Navigate the Challenges of Drug Development from Lab Bench to Medicine Cabinet

We understand the regulatory burdens imposed upon drugs and biologics. Biopharmaceutical companies discover and develop innovative products to solve today’s biggest healthcare issues. However, global regulatory bodies continue to raise expectations and enforce policies making the product development process increasingly complex. Consequently, leaders within biopharma companies must continuously examine all aspects of their development process and answer questions such as:

• How can we leverage FDA and other global health authority expedited approval programs?
• How can we reduce operating costs across manufacturing and quality divisions by adopting lean practices?
• As a small start-up, how can we overcome limited resources that may hinder the performance of clinical studies or optimization of the supply chain?
• How do we effectively de-risk the preclinical drug development process to advance our treatment to a point of attracting investors and partners to support clinical development, manufacturing, and commercialization?

Custom Solutions for Each Product’s Unique Pathway to Market

Pearl Pathways helps companies answer these questions and others every single day. Additionally, once answers to such questions are identified, we have the expertise and resources to execute the required strategic or tactical initiatives to advance each product’s unique development pathway.

Pearl Pathways’ advisors possess decades of experience across a wide array of therapeutic areas, allowing for efficient work with small startups to large multinational biopharmaceutical teams at any stage of the product development lifecycle. Rapid advancements in the medical innovation landscape (e.g., biologics and cell therapies, personalized medicines, etc.) demand adaptive approaches to streamline and optimize the regulatory process. Therefore, we avoid “one size fits all” strategies and provide custom solutions that meet the unique needs of each product and team.

Comprehensive End-to-End Solutions to Support Every Stage of the Drug or Biologic Lifecycle

Partnering with Pearl Pathways means that you will receive comprehensive solutions from a highly experienced cross-functional and collaborative team. We have broad experience across therapeutic areas, accelerated approval pathways, rare and specialty patient populations, and innovative technologies including orphan drugs, oncology, pediatrics, combination products, and digital therapeutics. Our service offerings include:

Regulatory

• Initial and ongoing regulatory strategy
• Full-service submission support for regulatory applications (IND, CTA, NDA, MAA, ANDA, BLA, Drug Master Files, etc.), as well as ongoing maintenance filings
• Regulatory publishing and electronic Common Technical Document (eCTD) submission support
• Communication support with FDA and other Global Health Authorities
• Clinical, Non-Clinical, and CMC Development
• Due diligence of new product platforms/technologies

Quality Compliance

• GxP Quality System implementation and management
• GxP audits of facilities, labs, suppliers/vendors, quality systems, etc.
• Validation and remediation support
• Supplier management and oversight of CMOs, CROs, etc.

Clinical Services

• Full-service CRO services for Phase I-IV clinical trials
• Medical writing support for regulatory applications, clinical research documentation (e.g., protocols, ICFs, IBs, CSR, TMF plans, med etc.)
• International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and research site support services
• Biostatistics and data management
• Pharmacovigilance

Independent Review Board (IRB)

• Central or Single IRB services for multi-site drug trials
• Flexible working model for local institutional review boards
• Fast turnaround times for IRB review services of all research involving human subjects

Ready to discuss how to advance your drug or biologic to market faster via custom, product-specific strategies?