Rachel Leahy, PhD, RAC
Founder & Principal Consultant
A scientific foundation for every compliance challenge
Rachel Leahy, PhD, RAC is the founder of Molecularity Compliance Consulting LLC, an independent regulatory affairs and quality consulting firm serving biotechnology, pharmaceutical, medical device, and healthcare organizations across the product development lifecycle.
With more than 12 years of experience in pharmaceutical and biological product development, Rachel brings a rare combination of deep scientific training and applied regulatory expertise. Her doctoral work in cellular and molecular biology provides the scientific foundation that distinguishes her approach from compliance consultants whose backgrounds are purely administrative or legal — enabling her to engage with technical data, manufacturing processes, and clinical science with the same rigor she applies to regulatory frameworks.
Rachel holds the Regulatory Affairs Certification (RAC-US), the foremost credential in the regulatory affairs profession, awarded by the Regulatory Affairs Professionals Society (RAPS). She operates Molecularity as an independent consultancy and subcontracts through CERobs Consulting, serving clients ranging from clinical-stage biotechs to established pharmaceutical and biologics manufacturers.
Areas of Deep Expertise
Rachel's consulting practice spans the full GxP landscape, with particular depth in the following areas:
GCP auditing and clinical quality systems
CMC quality and biologics manufacturing
Regulatory submissions — NDA, BLA, IND, 510(k)
FDA inspection readiness and remediation
Vendor qualification and CDMO oversight
Real-world evidence (RWE) quality frameworks
Data integrity and 21 CFR Part 11 compliance
Technology transfer and PPQ program support
Cell and gene therapy quality systems
HIPAA and clinical privacy compliance
Professional Background
Rachel's regulatory career spans both industry and independent consulting, with experience supporting clients through FDA, EMA, and MHRA inspections; pre-approval and post-approval inspection readiness; and submissions across multiple product categories including novel biologics, rare disease programs, and complex medical devices.
She has conducted GCP audits of clinical research organizations and investigator sites, developed quality frameworks for real-world evidence studies, led CAPA development and effectiveness verification programs, and provided strategic guidance on change control, deviation management, and supplier qualification under ICH Q10 and 21 CFR Parts 211, 600, and 820.
A published scientific author, Rachel brings the analytical discipline of academic research to every client engagement — synthesizing complex regulatory requirements, manufacturing data, and organizational context into practical, defensible compliance strategies.
Molecularity is a member of the Regulatory Affairs Professionals Society (RAPS) and actively contributes to industry dialogue on quality systems, regulatory science, and inspection readiness.