Consulting Services

Compounding

Gates Healthcare’s industry-leading consultants develop programs designed to improve clinical practices of both large and small compounding pharmacies.

Gates’ consulting services are comprehensive and range from design and licensure to full compliance and accreditation with everything in between.

See Compounding Services

Community Pharmacy

Gates Healthcare Associates is a regulatory consulting firm that specializes in the compliance of our nation’s independent community pharmacies, independent pharmacy franchises, and independent chains. Our services are tailored to assist with pharmacy operations, regulatory compliance, policies and procedures, quality assurance, disciplinary action assessment or monitoring, and inspection or survey programs.

Our team of experts were heavily involved in the development and implementation of new programs for accreditations and inspections including CPPA®, VPP® and state projects, in training of state board compliance officers, and in maintaining and updating existing NABP accreditation programs to include emerging issues and changes in regulations and standards.

See Community Pharmacy Services

Hospital Pharmacy & Radiopharmaceuticals

Hospital-based pharmacy practice has never been more exciting and more challenging. New federal and state laws and regulations make compliance an everyday concern. Demanding workplace and patient safety standards necessitate complex design and advanced training.

Gates Healthcare’s renowned experts have helped some of the nation’s most respected academic medical centers develop and operate their pharmacies, while also assisting small community hospitals. Our team of experts stands ready  to ensure that the hospital pharmacy is meeting and exceeding its goals in this time of intensive regulatory scrutiny and oversight.

See Hospital Pharmacy & Radiopharmaceuticals Services

503B Outsourcing Facilities

On November 27, 2013, the Drug Quality Security Act (DQSA) created a new section 503B in the Federal Food, Drug, and Cosmetic Act (FDCA). Under section 503B, a compounding pharmacy can become an outsourcing facility.

Outsourcing facilities must comply with current good manufacturing practice (CGMP) requirements and will be inspected by the FDA.

See 503B Outsourcing Facilities Services

Training & Education

Becoming a healthcare professional signifies the commitment to advancing the knowledge and skills to the profession and ultimately providing quality care and safety to the patients.

Gates Healthcare’s specialty is tailoring training & education programs specific to the individual practitioner’s facility and operational needs.

See Training & Education Services

Medical Marijuana

Medical marijuana refers to the use of cannabis and its cannabinoids to treat disease or improve symptoms. Medical cannabis can be administered in a variety of methods, including vaporizing, ingesting medicated treats, taking capsules, or using oral sprays.

The rollout of medical marijuana facilities nationwide has been bumpy, with lawsuits and controversy delaying the openings. Gates Healthcare Associates will participate as part of your team to provide specific consulting services to help speed licensing and avoid delays.

See Medical Marijuana Services

Long-Term Care

Gates Healthcare Associates is a pharmaceutical and healthcare consulting firm that develops programs designed to improve clinical practice and maximize reimbursement of Long-Term Care facilities. Our innovative solutions and services work to ensure your facility meets the challenge of maintaining compliance with strict laws and regulations while helping to increase profitability.

Gates Healthcare’s LTC consultants consist of nationally recognized consultants having served in key leadership roles in a variety of organizations such as: State Board of Pharmacy, Department of Public Health, Medicare Part D Task Force, American Society of Consultant Pharmacists, and the Institute for Safe Medication Practices.

See Long-Term Care Services

DEA Compliance

Gates Healthcare Associates support our clients to navigate their way through DEA rules, regulations and inspections. GHA works closely with key stakeholders to ensure harmonization of approach and plays a critical role in ensuring company compliance.

GHA’s DEA regulatory consultants have conducted extensive research and organizational audits that developed solutions across decision making, business processes, sales monitoring, prescription monitoring and training for companies of all sizes in the pharmaceutical industry including drug wholesalers, hospitals and specialty pharmacies.

See DEA Compliance Services

Strategic Planning

Gates Healthcare Associates helps healthcare organizations develop strategic plans that resolve logistical and procedural challenges and maximize opportunities for growth.

See Strategic Planning Services