Clinical Compliance Solutions is a company founded by Sharon Reinhard to provide regulatory and compliance solutions to small and mid-sized biotech and pharmaceutical companies. Ms. Reinhard has 18 years of experience in clinical development, operations, compliance and quality assurance at large companies. She offers interim leadership, gap analyses, SOP development, inspection readiness strategies, audits and training to help clients stay compliant with evolving standards. Her services are customized based on a company's size, maturity and complexity.

1. Clinical Compliance Solutions, LLC
Right-sized scientific, regulatory and compliance solutions that you can implement and sustain
After 18 years of working in the pharmaceutical industry, Sharon Reinhard, M.S, created Clinical
Compliance Solutions, LLC to offer a variety of services to small to mid-size companies that may not
have permanent senior leadership in clinical development, operations and quality assurance or who
are experiencing unexpected growth, a change in strategy or increased demands.
Ms. Reinhard is a thought-leader in the area of GCP, risk-based approaches, quality by design and
inspection readiness, having chaired and presented at more than a dozen conferences during the
past 5 years. During her career, she has supported over a dozen NDAs and regulatory inspections.
Sharon’s experience is comprised of a unique blend of roles in clinical development, operations,
compliance and quality assurance. Three of her greatest accomplishments have been reducing
time-to-results by 50%, reducing clinical operating costs by 30% and implementing a new SOP
system within 6 months. She has worked in mid and large size companies, as well as start-ups.
Let Clinical Compliance Solutions keep your organization current with evolving standards by
providing solutions that are customized to the size, maturity and complexity of your company!
Clinical Compliance Solutions offers the following services to
Pharmaceutical Companies, Biotechnology firms and CROs:
Clinical & Regulatory Services Compliance & Quality Assurance Services
 Interim/Temporary Senior
Leadership in Clinical Development or
Operations
 Gap Analyses of Clinical Systems
 Timeline & Budget Development
 Outsourcing Strategies
 Protocol Development
 Program Feasibility
 Vendor Selection & Assessments
 Development of Risk-Based
Approaches to Clinical Operations &
Outsourcing
 Vendor Oversight
 FDA briefing packages
 IND/NDA authoring
 Interim/Temporary Senior Leadership
in Compliance or Quality Assurance
 Gap Analyses of GxP systems
 Development of Quality Management
System
 Development of GCP-SOP system
 Provide Inspection Readiness
Strategies, Training & Support
 Develop Audit Strategy & Plans
 Perform Vendor, Site & Document
Audits
 Develop Risk Detection & Mitigation
Plans, including CAPA
 GCP training & tools
Drug & Biologic (505b(1) & 505b(2)) therapeutic experience includes but not limited to:
Pain (LBP, OA, Surgical) Oncology Rheumatoid Arthritis
Parkinsons Disease Multiple Sclerosis Anxiety/Depression
Cardiovascular PTSD ADHD
Anti-Infectives Gastroenterology Mens / Womens Health
Orthopedics Botulinum toxins Pediatrics
Career History: University of Pennsylvania, Wyeth, Sanofi, Shire,
Solstice Neurosciences, Endo and iCeutica (see Curriculum Vitae)