Giuseppe Oppio has extensive experience in a broad range of areas of the Pharmaceutical industry. He is a native Italian that has served as a consultant and Project Manager in Italy, Switzerland, Ireland and the United States. He is specialized in coordinating Quality Systems (cGMP) audits, operator and management training, development of process risk analysis programs, and technology transfer. He has an excellent record assisting clients in the preparation for successful FDA inspections and for the proper implementation of CAPA systems.
Craig Kruman advises clients on general matters related to FDA regulatory affairs. He has extensive knowledge of PDUFA and GDUFA fees, Drug Registration and Listing, Establishment Registration, product labeling, and U.S. Agent compliance for foreign facilities. His strong financial background also helps to focus on certain FDA fee waivers or reductions.
Charles advises clients on aseptic processing, cleaning validation, process validation, inspection for foreign particulate matter, technology transfer and quality systems to ensure readiness for pre-approval inspections. His expertise includes the development and management of project plans to achieve successful regulatory inspections.
Juan is a highly competent Microbiologist with a focus on analysis, methods and equipment validation, technology transfer, and laboratory supervision and management. He has direct experience dealing with validation of microbiological tests, implementation of new testing technology in the microbiology laboratory, sterility testing of isolator systems, bacterial endotoxin technologies, particulate matter testing, and environmental monitoring devices. He assists clients with revision and adoption of new procedures and the proper implementation of laboratory regulatory guidelines.
Susan is a highly knowledgeable Regulatory Affairs professional with 36 years of experience working in the pharmaceutical industry; 30 years in Drug Regulatory Affairs and 6 years in Pharmaceutical Research and Development. She has extensive experience in Chemistry, Manufacturing, and Controls (CMC), regulatory strategy, preparation and organization of regulatory submissions including New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), Drug Master Files (DMFs) and Investigational New Drug Applications (INDs). Expertise also includes preparing for and organizing pre-IND, End-of-Phase II, pre-NDA, Type B and Type C meetings with the FDA.
Bill assists clients in the preparation of Abbreviated New Drug Applications (ANDAs). He has covered immediate and extended-release tablets and capsules, liquids, topicals, sublingual, and ophthalmic dosage forms. He also works with Paragraph IV filings. He has experience in evaluating post-approval CMC changes and preparing supplements for regulatory approval as well as Annual Reports. He has also been involved in the design and implementation of pharmacovigilance programs. His background is in analytical chemistry and management of ICH compliant stability programs.
Mike has more than 30 years of experience in regulatory affairs, working with large companies, small start-ups, and contract research organizations. He has been involved with at least 15 NDA approvals for NCEs and many other important supplemental NDAs. He has also helped file more than 100 INDs and has been the FDA contact person for many of these applications.
Irisha oversees the conversion of paper into electronic eCTD submissions. She uses industry-standard publishing and document management systems. She is highly experienced in managing the entire electronic submission and archive process.
Ken advises clients on general cGMP compliance, product development, product and process validation, facility design, analytical development, technology transfer, and documentation control. He has extensive knowledge of drug development for new chemical entities and multi-source products, as well as developmental and regulatory requirements for appropriate manufacturing of existing or proposed chemical moieties.
Robert has significant experience in QA / Compliance including, quality program design / implementation, quality agreements, site and document audits, PAI-readiness inspections, CAPA assessment, etc. He is an American Society for Quality (ASQ) Certified Quality Auditor (CQA). He also has an extensive background in Drug Product formulation/manufacturing and analytical development as well as CMC Regulatory Affairs.
Robert has over 30 years of Quality Assurance and manufacturing process development and validation experience in the pharmaceutical and medical device industries. His technical expertise includes aseptic and sterile processing, quality risk management, contamination control and monitoring, as well as establishing comprehensive Quality Management Systems. He has extensive knowledge of FDA, Health Canada and EMEA cGMP regulations and technical standards. He assists clients prepare for successful regulatory inspections well as respond to regulatory citations and other enforcement actions. He can also deliver world-class training.
Pino previously worked over 20 years in the pharmaceutical industry, with expertise in the areas of global marketing and licensing. A lawyer by training, he spends most of his time working in pharmaceutical business development and M&A. His diversified expertise and intimate knowledge of the European pharmaceutical marketplace offers valuable insight in deals which require an understanding of different business cultures.
Steve provides outsourced pharmacovigilance services for investigational and marketed drugs. Services include 24/7 call center staffed with pharmacists and nurses for intake of adverse events, assessment of adverse events for seriousness and expectedness, coding adverse event terms using MedDRA, writing case narrative for MedWatch reports, and preparation and electronic submission of regulatory reports for FDA, EMA, Health Canada and other regulatory agencies.
Martí focuses on the market in Spain and has promoted, directed, and managed research and innovation projects in both the public and private environments. He has participated in the founding of several technology-based companies and has worked on tech-transfer projects to bring science to market. He helps clients define and implement strategies to manage the interface with innovation service providers including funding, regulatory affairs, and technical and strategic alliances.
Matt has over 25 years of experience in GMP manufacturing environments in Pharmaceutical, Biotechnology and Medical Device companies. He possesses validation and quality assurance expertise in the manufacturing of drug products (oral solids, powders, creams, ointments), aseptic/sterile processing, cell culture and fermentation. He has managed validation department staff at large and mid-sized companies and has started-up plants as the validation project manager, representing the validation department during successful regulatory inspections (FDA, MHRA) and on-site presentations at FDA.
Richard is a Quality Assurance consultant with over 37 years of pharmaceutical industry experience in Quality Assurance, Quality Control, and Validation functions for a variety of product categories including active pharmaceutical ingredients (API), API sterile components, small volume parenterals, and solid oral dosage forms. His background includes managing GMP Auditor Teams, compliance auditing and issues resolution, policy development, training, and project management. Technical competencies include extensive knowledge of worldwide regulatory requirements; equipment, utility, process, and cleaning validation; specialization in automation validation; compliance auditing and training; and preparation of SOPs and related documentation.
Brian is a GMP consultant with hands-on experience managing new drug approvals with extensive experience in Food and Drug Administration/industry, quality and regulatory, U.S. and foreign pharmaceutical manufacturing. He has extensive experience in FDA, quality and regulatory, U.S. and foreign pharmaceutical manufacturing. Experience with solid oral dosage forms, API’s, non-sterile liquids and topicals, GMP auditing and SOP writing. Specialties include ICH and Regulatory Compliance, CGMP, Quality Systems, Risk-Based Auditing, Quality Assurance, Quality Control, CAPA, Investigations, Equipment Qualification, Process Validation, Fermentation, and Chemical Synthesis.
Fred is a former FDA compliance/enforcement official, with management positions in CDER’s Office of Compliance and ORA’s Office of Enforcement, as well as an experienced GMP/labeling/new drug consultant.
Alain is our partner in France. He is focused on Regulatory Affairs, Quality Assurance, pricing files, and clinical trials for drugs, devices and cosmetic products.