About Us
Experience You Can Count On
Our service includes a comprehensive consultation in Global Clinical Drug Development/Registrations/Regulatory Strategies and Portofolio Assessment for optimum Product Portfolio driven by the Business Objectives. We have over 35 years of Pharmaceutical Experience in Successful Global Drug Development Programs and Health Authority liaison. We customize portfolio develoment strategies to align with your business model and desired therapeutic areas. Clients rely on us for:
· . Regulatory strategies, in conjunction with business objectives that can translate into plans and operational deliverables
. Early and Late Stage Development across multiple therapeutic areas.
· Meetings with health authorities/Health Authority liaison for routine and specific Meetings including, pre-IND, Pre NDA/BLA and Advisory Committee Meetings
· Technology Transfer and liaise/manage contract manufacturers
· Life Cycle Management
· Global Labeling Strategies and Labeling Compliance
· Advertisement and Promotion
· Pharmacovigilance
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Our consulting process is designed to empower your team by providing the informtion required to pursue your Corporate Goals and Objectives. Talk to us today about how we can support your business growth,
Professional Profile and Achievements
Site Content
Diverse experience in Research and Development, Clinical, Regulatory Affairs, Medical Affairs and Pharmacovigilance.
Therapeutic area experience includes Anti-infective (antibiotic, antiviral and antifungal), Cardiovascular, Endocrine and Metabolism, Pulmonary, CNS, Men's Health, Women's Health, Dermatology (including skin care and cosmetics/aesthetics), Immunology, Oncology, Ophthalmology, Over the Counter Products, Devices and Vaccines.
EXPERTISE
• Extensive experience in Global Clinical Drug Development/Registrations/Regulatory Strategy/Pharmacovigilance/New Business Development/Portfolio Management
• Strategic Clinical/Regulatory input towards new business development, licensing/acquisitions, joint drug development and Regulatory policy
• Leadership role in preparing internal company response to new regulatory guidance documents and policies and interaction with external industry associations for preparing joint industry position
• Global labeling Strategies and labeling Compliance
• Management of Clinical Programs (Phase I-Phase IV) across multiple therapeutic areas; including, protocols, investigator meetings, interaction with KOLs and safety data monitoring committees
• Experience in multiple therapeutic areas in Drugs, Biologics. Diagnostics, Devices, Over the counter products and Rx to OTC switches, 505 (b) 1 and (b) 2 applications.
• Experience in all aspects of safety management (Clinical and Post marketing), integrated safety summaries, REMS/RMP/PSURs and company responses to assessment reports.
• Advertising and Promotional compliance/Interaction with OPDP
• Accomplished approval of NDAs, sNDAs and MAAs. Successful interactions with the FDA across ODE I-ODEV, OGD, CDRH, DDMAC and other regulatory agencies in Canada and Europe.
• Non-Clinical and Clinical Research for Drug Development. Management of Clinical Operations for overall study management, Safety reporting and Good Clinical Practices
• Technology Transfer for Contract Manufacturing and Plant Rationalizations
MAJOR ACCOMPLISHMENTS
• Served as interim Head for Regulatory and Safety for a major Pharmaceutical company in Europe.
• Successful in enabling major international companies to establish clinical operations in the United States, including initiating clinical programs by interaction with the FDA, selection of contract research organizations for clinical research and contract manufacturers for clinical supplies.
• Managed a complex mature product with successful interactions with the FDA to continue marketing the product.
• Accomplished cGMPs to enable a company under consent decree resume CMC activities
• Accomplished approval of NDAs, sNDAs and MAAs and Rx to OTC Switch Applications. Key switch applications included antifungal, pain and respiratory products.
• Successful interactions with the FDA across ODE I-ODEV, OGD, CDRH, OPDP and other regulatory agencies in Canada and Europe.
• Demonstrated scientific contribution, influence, negotiation and consensus building in a highly “ matrixed” global environment