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bulk pharmaceutical chemical manufacturing

  

chemical production

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industrial chemical production

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active pharmaceutical ingredient

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pre-approval inspection

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bulk drug

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bulk packaging material

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generic drug manufacturing

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contract manufacturing

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pharmaceutical industry

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chemical processing

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pharmaceutical manufacturing

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pharmaceutical reactor

 

Bulk Pharmaceutical Chemical Manufacturing Experts

The following experts are available as bulk pharmaceutical chemical manufacturing consultants and bulk pharmaceutical chemical manufacturing expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Bulk Pharmaceutical Chemical Manufacturing - Chemical manufacturing of the active ingredient(s) that are components in pharmaceutical products.

Synonyms:  BPC manufacture, BPC manufacturing, BPC production, bulk drug chemical manufacturing, bulk pharmaceutical chemical manufacture, bulk pharmaceutical chemical production

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1 to 25
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Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence
Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, ... See full profile

Illinois (IL), USA

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile

Québec, Canada

Expert in CRO in Medicinal Chemistry, Pharmaceutical Chemistry, API, CRAMS, Speciality Chemicals, Training
Expert received his PhD in synthetic organic chemistry from the University of Hyderabad. He has 2 years of post-doctoral experience in synthetic and physical organic chemistry from University of Houston. He also worked on chiral polymers and energetic ... See full profile

India

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of ... See full profile

Massachusetts (MA), USA

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

Expert in Validation
Expert has been an independent Validation Consultant for around 10 years; he is responsable for the management of validation projects. He supervises resources acting as a project manager and is also responsible for the development and execution of ... See full profile

Puerto Rico

Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, ... See full profile

Maharashtra, India

Expert in Pharmaceutical Process Research, Development, and Manufacturing
Expert has 17 years experience of research, development and manufacturing of APIs. Expert has three patents from research, development and manufacturing of etoposide and etoposide phosphate. He also has extensive experience with platinum ... See full profile

Pennsylvania (PA), USA

Expert in Specialty and Fine Chemicals, Pharmaceuticals, Resins, Coatings
He has worked in the process development, manufacturing related to the technologies, chemistries. He has also worked in intellectual property strategy, commercialization of many different technologies. He is able to do this as he has cross- fertilized ... See full profile

Ohio (OH), USA

Expert in Legacy Application Support: Manage, Measure, Improve Using ITIL V3 Service Management Life Cycle
Expert spent 10 years as Director of MIS for the Revlon Health Care, Pharmaceutical Division and managed all IT activities for 5 companies within the division. Major accomplishments were designing and implementing complex pharmaceutical order ... See full profile

Pennsylvania (PA), USA

Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA

Expert in Biopharmaceutical Development
Expert, PhD, is a consultant in the field of BioPharmaceutical Development. He has over 23 years of biotech industry experience in biotherapeutic and diagnostics development, having held senior positions at several biotech companies, most ... See full profile

Massachusetts (MA), USA

Expert in Process Chemistry: R&D, GC, HPLC, Flash Chromatography, NMR, IR, Mass Spec, & LCMS, Synthetics
He has experience with process research and development, including scale-up to 10- and 15-L reactors. Included in his background is experience with the design, execution, and optimization of multi step organic syntheses aimed at both pharmaceutical ... See full profile

California (CA), USA

Expert in FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action in a ... See full profile

Michigan (MI), USA

Expert in New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to ... See full profile

Arizona (AZ), USA

Expert in FDA Compliance, Pharmaceutical New Products, Management Training, Seminars, Inspections, Audits
During his employment with the Food and Drug Administration, Expert received five grade promotions, with his last position being that of Director of the Science Branch of the Philadelphia District. Expert's area of responsibility included all the ... See full profile

Georgia (GA), USA

Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in ... See full profile

New Mexico (NM), USA

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), USA

Expert in Specialty Chemicals,Pharmaceuticals, Nutrition, Composites,Synthetic Resins, Engineering Plastics
Mr. N.V.Expert has over 10 years of operational, business, strategic and executive leadership experience in this area having run DSM's pharmaceutical businesses in this area; he also led the Ant-Infectives business in the Asia Pacific, Middle East and ... See full profile

Haryana, India

Expert in Medicinal Chemistry, Synthetic Organic Chemistry, Drug Discovery, Pharmacokinetics
Expert has strong knowledge in asymmetric multi-step organic synthesis, scaffold design and library development with ability to solve challenging chemistry problems and have authored peer-reviewed articles and patents. Expert is a synthetic and ... See full profile

Wisconsin (WI), USA

Expert in Manufacturing, Automation, Engineering Design, Operations, Control Engineering, Food Factories
Long-standing designer of complex factory automation systems. Expert witness work has involved determining causes of program failures that have led to serious factory fires and equipment failure, as well as failure to perform to specification. See full profile

Devon, United Kingdom

Expert in Powder Flow and Bulk Solids Handling Technology
Expert is Professor in Particle and Bulk Technology . He has vast experience of working with all aspects of powder and bulk technology and solving problems in the flow and processing of powders, granules and lump materials over a full range of ... See full profile

Kent, United Kingdom

Expert in Green Energy Controls, Automotive Manufacturing, Pharmaceutical Process Controls
Expert has designed patented systems which increase manufacturing productivity, flexibility, and quality while drastically reducing inventory in discrete and continuous manufacturing industries such as automotive, machine tool, pharmaceutical ... See full profile

Indiana (IN), USA

Expert in Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition of ... See full profile

New Jersey (NJ), USA

Expert in Process Automation, including: Control, Computer Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for ... See full profile

Indiana (IN), USA

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