ABOUT US:

Flourish Regulatory and Quality Consultants, LLC based in Redwood Shores, California provides professional clinical regulatory affairs and clinical quality assurance & compliance strategic and operational consulting services to support all phases of product development, global registration and maintenance activities for pharmaceuticals, biologics and medical devices.

Our mission is to partner with clients to assist with the development of great scientific ideas and deliver on transformative therapies to treat patients enduring diseases of unmet medical need.

Flourish is a small but rapidly growing privately owned agency that provides expert personalized service to small start-ups, mid-sized companies, and to large well established global organizations during times of high resource demand.

Our team of professionals have extensive experience across the full product life-cycle for pharmaceuticals, biologics and medical devices from early drug development through registration, post-approval product maintenance and market withdrawal, across various product types and therapeutic areas including; oncology, infectious diseases, neurology, orphan diseases and other high demand areas.

Flourish continues to build on our reputation as a solutions oriented advisor, supportive partner and integral team member. By using high quality, best value and low risk approaches, we collaborate closely with clients to develop and

implement customized project strategies to support business opportunities and objectives.

Flourish is dedicated and proud to support the development of great scientific ideas, from early vision concepts to world changing medical products.

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OUR TEAM:

Joseph A Fisher

Joseph Fisher is co-founder and lead regulatory affairs advisor at Flourish, Regulatory and Quality Consultants, LLC.

With over 20 years of diverse regulatory affairs experience in the biopharmaceutical industry, he has provided expert strategic regulatory leadership and guidance to a range of companies from small start-ups to large global organizations, during early-phase development through registration and marketing, for small molecules, biologics, cell-based therapies and combination products, with indications in oncology, cardiology, gastroenterology, neurology, ophthalmology and dermatology.

He has extensive experience with leading teams through the development and management of innovative regulatory strategies, risk analysis and assessments, and contingency planning in support of global projects.

Joseph also has expansive experience with leading submission teams through the compilation and dispatch of global regulatory submissions, and guiding teams through the preparations for global health authority meetings and leading interactions with health agencies.

He currently leads and serves as head regulatory advisor to a global team of regulatory professionals.

He encourages our professionals to explore and discover new approaches, to engage deeply with colleagues, clients and global health agencies, to think creatively, out-of-the-box, and when feasible, propose innovative strategies that may accelerate development timelines and deliver transformative therapies to patients sooner.

During his free time, Joseph enjoys coaching girls youth softball and basketball, and supporting local charities that provide emergency disaster relief to families in need.

Joseph Fisher holds a BS in biology from Adelphi University in Garden City, NY and attended the MS degree graduate medical biology program at Long Island University in Brookville, NY.

Renee A Fisher

Renee Fisher is co-founder and lead quality assurance and compliance consultant at Flourish Regulatory and Quality Consultants, LLC. With over 20 years of diverse clinical quality assurance experience in the biopharmaceutical industry, Renee Fisher has provided expert quality assurance & compliance guidance and operational support to a range of companies, from small start-ups to large global organizations.

She has provided leadership and guidance during the conduct of several global clinical trials (phase I through IV) by providing guidancee and expertise regarding investigator site, vendor, study documentation audits and health agency inspections. Her experience includes the management of investigational and registered products with indications in oncology, gynecology, infectious disease, rare disease, cardiology, gastroenterology, neurology, ophthalmology and dermatology.

She has comprehensive knowledge and experience in supporting teams by providing in-depth insights for detecting compliance gaps, creating visionary solutions for management and guiding teams through the implementation of compliance solutions. Therefore, limiting business risk, increasing confidence for successful regulatory authority inspections and long-term achievement of total compliance in study conduct. She has the ability to create and influence "high quality" organizational practice for clinical study conduct and maintenance.

Renee Fisher currently teaches an after-school program focusing on religious education for elementary and middle school children. She also mentors high school juniors and seniors enrolled in a biotechnology program at a local high school. The program provides students with science-based courses in chemistry, english and social studies, and an opportunity to interact with professionals working in the biopharmaceutical industry.

Renee Fisher holds a BS in health care administration from St. John's University, Queens, NY and a MS degree in the graduate program for Nutritional Sciences from New York Institute of Technology in Old Westbury, NY.

The Team:

Our team of professionals have extensive experience across the full product life-cycle for pharmaceuticals, biologics and medical devices from early drug development through registration, product maintenance and market withdrawal, for various product types and therapeutic areas including; oncology, infectious diseases, neurology, orphan diseases and other high demand areas.

Flourish, Regulatory and Quality Compliance Consultants maintains a highly selective hiring and placement process. We hire and assign projects only to the most highly experienced specialized professionals. Client work and projects are assigned to individuals that best match the requirements for the opportunity by related work experience, years of applicable experience and formidable education.

OUR SERVICES:

Flourish, Regulatory and Quality Consultants, LLC provides professional clinical regulatory affairs and clinical quality assurance compliance strategic and operational consulting services to support all phases of product development, global registration and post-approval maintenance activities for pharmaceuticals, biologics and medical devices.

We are a full service clinical regulatory affairs and clinical quality assurance compliance provider, that can supply supplemental personnel support to alleviate the commitment and cost for full-time dedicated staff, provide extra assistance to meet aggressive project timelines and in moments of high resource demand.

Flourish RA and QA Consultants, LLC has helped many clients, both large and small, achieve their development and project milestones by providing and executing on customized strategies for success.

Clinical Regulatory Affairs Services:

Flourish RA and QA Consultants, provides the following clinical regulatory services:

Provide expert strategic regulatory and operational support to project teams for early phase research & development through post-approval marketed product maintenance
Develop and maintain regulatory strategies, risk analysis and assessments, and contingency plans
Drive and manage projects according to developed and agreed upon regulatory strategies and timelines
Assist with the development and maintenance of target product profiles and target product labeling
Discuss available regulatory mechanisms, qualification criteria and determine eligibility for FDA and EU expedited development programs
Provide expert leadership and guidance to cross-functional submission teams during the planning, preparation, review and dispatch of global regulatory submissions to health agencies (for INDs, CTAs, DMFs, NDAs, BLAs, MAAs, amendments, supplements and correspondences)
Provide leadership and management support for regulatory agency meetings and communications (including; the preparation of meeting requests and briefing documents, leading team rehearsals, facilitating health agency meetings, authoring executive summaries and meeting minutes, and managing any pre (written responses) or post meeting communications or actions (requests for clarification or responses to health agency requests for information)
Manage and track commitments to health authorities, client communications and actions, program maintenance activities and submissions (annual and safety reporting)
Develop and maintain regulatory related standard operating procedures (author and maintain SOPs, provide training and maintain records)
Present on and provide training on current drug regulation policy and guidance
Conduct regulatory and competitive assessments and report on findings

Clinical Quality Assurance and Compliance Services:

Flourish RA and QA Consultants, provides the following clinical quality assurance & compliance services:

Provide expertise and guidance on current Good Clinical Practices (cGCP) across the full clinical development life-cycle (Phase I through Phase IV) for pharmaceuticals, biologics and medical devices
Develop and maintain sustainable compliance programs including, implementing corrective and preventive action plans and inspection readiness protocols
Lead GCP investigations for clinical quality issues including; identifying root cause, developing appropriate corrective and preventive actions, track actions and confirm effectiveness, provide recommendations for reporting issues to regulatory authorities
Develop and implement risk based GCP audits and compliance strategies to assess the impact of audit findings and other identified compliance risks to subject safety, data integrity and business operations
Identify and report on clinical study compliance issues and recommend mitigation action plans
Manage and conduct domestic and international GCP risk-based audits of investigator sites, study documents, databases, vendors, partners and internal systems- for compliance with cGCP, company policies and procedures; assess the impact of audit findings on subject safety, data integrity, and business operations
Analyze and report on GCP quality metrics, and recommend any required actions or changes to monitoring plans and/or quality plans
Provide inspection preparation instruction and guidance (for investigator sites/sponsors/CROs) including; pre-audit study documentation review, conduct mock inspections; administrative preparations, preparations for inspector audit requests, questions and comments, post-audit actions
Develop and maintain standard operating procedures for GCP clinical study conduct, quality assurance and compliance, and clinical project management
Conduct gap analysis on current procedures to determine any required revisions and/or additions
Provide training on current GCP policy and guidance

Flourish partners with clients to support the development of promising ideas that will become the cures and treatments of tomorrow.