Consulting Services

Accreditation Support

There are a multitude of pharmaceutical and healthcare accreditation programs. Each offering a diverse set of standards that go above and beyond quality and saftey parameters set by regulatory bodies. Gates Healthcare Associates, Inc. helps prepare our clients to meet the accrediting standards as well as provide mock inspections to facilitate readiness.

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United States Pharmacopeia (USP) Compliance

Compounding practices must adhere to applicable USP General Chapters <795> for Non-Sterile Compounding, <797> for Sterile Aseptic Compounding, and <800> for Hazardous Drug Handling and Storage (effective Dec. 2019). Gates Healthcare Associates, Inc. guides its clients to understanding the importance of the quality and saftey standards as well as achieving compliance within their specific practice.

See United States Pharmacopeia (USP) Compliance Services

DEA Compliance

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

Our 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.

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FDA Compliance

FDA is concerned about the risk to patients from compounded drugs that do not meet the conditions in sections 503A or 503B. Gates Healthcare Associates, Inc. prepares its clients (either 503A compounding facilities, or 503B outsorucing facilities) to be FDA inspection ready, or support with any Form 483 response and remediation from previous inspections.

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State Regulatory Compliance

Complying with state regulations can be complicated, especially with multiple state licesnes. Gates Healthcare Associates, Inc. can prepare your practice for State Board inspections as well as assist with any remediation efforts derived from post inspections.

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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 Associates, Inc. specialty is tailoring training & education programs specific to the individual practitioner’s facility and operational needs.

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Pharmacy Sales & Acquisition Support

Whether you are interested in buying or selling your pharmacy, Gates Healthcare Associates talented experts can maximize your efforts to find the best opportunites.

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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