BioAcuity Consulting Inc. Announces Hiring of Dr. Jean-Pierre Metabanzoulou to Lead Regulatory Affairs Practice

Dr. Metabanzoulou brings over three decades of Regulatory, CMC, and Quality experience to the BioAcuity Consulting Team.

OAKVILLE, ONTARIO, CANADA, December 3, 2024 /EINPresswire.com/ -- BioAcuity Consulting Inc. is thrilled to announce the addition of Dr. Jean-Pierre Metabanzoulou, PhD, MBA, as Principal, Regulatory Affairs, CMC & Compliance to the company. This brings a new name to our group of Health Canada & FDA regulatory SMEs as well as expanded service offerings for our clients, allowing us to better support regulatory strategy, submissions, and product lifecycle management needs.

“We are excited to add Dr. Metabanzoulou’s vast regulatory knowledge, expertise and proficiency with Health Canada & FDA to our exceptional team of Subject Matter Experts.” said John Rydall, President of BioAcuity. “The addition of his regulatory strategy skills and submissions experience, honed through past work at Merck & Co., Acasti Pharma, and Pharmascience as well as other organizations, expands our existing capabilities and depth. Jean-Pierre will deliver strategic advice and tailored practical solutions to our clients, helping them navigate and balance complex regulatory strategy, achieve business needs, and ensure compliance with global regulations."

BioAcuity's Regulatory practice provides oversight and management in all phases of product development to ensure regulatory milestones are met. Our Regulatory Affairs experts:
• Provide regulatory strategy and submission guidance on FDA & Health Canada requirements for meetings and applications.
• Advise on current FDA, Health Canada & EMA regulations, guidance’s and expectations based on regular interactions with these Agencies.
• Offer experience liaising with FDA, Health Canada officials and reviewers as the primary point of contact for Sponsors & Clients.
• Share regulatory intelligence with clients by staying current on new regulations that may impact product development.
• Lead the regulatory process in managing the writing and review of regulatory documents, coordinating strategy discussions, managing timelines, publishing and application maintenance activities.
• Advise on optimal practices to create efficient, reviewer friendly applications that meet regulatory requirements.
• Fill interim & fractional Regulatory Affairs & Quality Assurance roles for Clients at both Senior & middle management levels.

BioAcuity's team provides product development support for Health Canada & FDA meetings, original submissions and lifecycle maintenance for various applications including:
• INTERACT
• Pre-INDs
• INDs
• NDAs (including 505(b)(2))
• ANDAs
• BLAs (including 351(k))
• Orphan Drug Designations
• Expedited Regulatory Pathways (BTD, FTD, RMAT, Accelerated Approval, Priority Review, etc.)

For more information about BioAcuity Consulting Inc. services please visit the company’s website at https://bioacuity.com/ and email us at info@bioacuity.com.

About BioAcuity Consulting Inc.
BioAcuity Consulting Inc. is a results-oriented biopharmaceutical / life-sciences consulting firm specializing in Regulatory Affairs, CMC, Clinical, Quality, Compliance, and Operations, serving start-ups to multi-national organizations in bio/pharmaceutical, biotech, medical device, natural health, and other life sciences industries. Our GMP / GLP / GCP / MDSAP regulatory compliance expertise and knowledge encompasses FDA, Health Canada, European, and Asian regulatory requirements, and guidelines.

John Rydall
BioAcuity Consulting Inc
+1 416-931-2271
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