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physical material


excipient compatibility


tablet manufacturing




melt extrusion tableting process


hydroxypropyl methylcellulose


drug formulation


microcrystalline cellulose




drug dosage form development




Excipient Experts

The following experts are available as excipient consultants and excipient expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Excipient - Inert material that is combined with an active drug in order to produce a drug dosage form.

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Expert in Biodegradable Systems for Controlled-Release Drug Delivery
Expert has a D.Sc. in bioorganic chemistry, a Ph.D. in polymer chemistry and over 25 years of experience in analytical and physical chemistry of biopolymers. In a very recent assignment Expert has established and directed an analytical chemistry ... See full profile

California (CA), USA

Expert in Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation ... See full profile

New Jersey (NJ), USA

Expert in Pharmaceutical Manufacturing
Expert career as a senior executive in the pharmaceutical manufacturing industry spans over 25 years and includes experience and understanding of every facet of the manufacturing process, in addition to strong skills in technical, operational ... See full profile

California (CA), USA

Expert in Pharmaceutical Development, cGMP, Formulation, Analytical Development, Poorly Soluble compounds
Expert is an expert in pharmaceutical development. He has 20+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, ... See full profile

Oregon (OR), USA

Expert in Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert's primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet ... See full profile

Florida (FL), 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 Pharmaceutical Solid Dose Forms
He has worked in the development and manufacturing of chewable tablets either for the delivery of locally (oral) acting drugs with a variety of excipients and basic tableting technology and in the development of medicinal candy products enclosing vitamins ... See full profile


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 Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, ... See full profile

Kent, United Kingdom

Expert in Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in ... See full profile

Pennsylvania (PA), USA

Expert in Drug Delivery, Formulation Development of NCE's, Preformulation, Stability, Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral ... See full profile

California (CA), USA

Expert in Powders and Tablet Manufacturing
Expert has developed tableting systems and products in the areas of pharmaceuticals, diagnostics, high-protein snack products, chlorine tablets, chlorine removal tablets, over the counter antacids, and vitamins. See full profile

Michigan (MI), 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 Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology
Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical ... See full profile

Ohio (OH), USA

Expert in Pharmaceutical, Cosmetics and Nutritional Supplements Product Development and Production
Expert has applied his pharmaceutical and cosmetic technology backgrounds to the development of fast acing and very effective after shaves especially aftershaves for problem skin. He has formulated soothing and conditioning aftershaves with natural and as ... See full profile

Massachusetts (MA), USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

Delaware (DE), USA

Expert in In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). See full profile

New Jersey (NJ), USA

Expert in Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development
Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated ... See full profile

California (CA), USA

Expert in Biotechnological Pharmaceutical Chemical Process Development Design Engineering
Expert has applied his extensive background in chemical engineering in various areas including pharmaceutical process and product development; developing new products for pharmaceutical and consumer industries; process, equipment, and analytical method ... See full profile

California (CA), USA

Expert in Industrial Statistical and Quality Control Applications
Expert is knowledgeable and experienced in the industrial application of attribute sampling standards (MIL-STD-105 / ANSI Z1.4) and variables sampling standards (MIL-STD-414 / ANSI Z1.9) to acceptance sampling inspection, which ... See full profile

New Jersey (NJ), USA

Expert in Controlled Release, Microencapsulation, Drug delivery, Taste Masking, Bioavailability Enhancement
Expert has almost twenty years of experience in the formulation of pharmaceuticals for controlled release delivery. This work includes drug bioavailability enhancement, tastemasking, enteric protection, tableting, colonic delivery, prevention of ... See full profile

Missouri (MO), USA

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 Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, ... See full profile

California (CA), USA

Expert in Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction
Expert has 25 years experience in pharmaceutical process scale-up, wet granulation end-point determination, compaction and tableting. He has published many articles on these topics, edited "Pharmaceutical Process Scale-up" handbook, and wrote chapters in ... See full profile

New Jersey (NJ), USA

Expert in Implementation and maintenance of Quality Management Systems, Pharmaceutical GMP for Excipients
Expert has applied his scientific background in various companies over the past 25 years. He has set up and managed spectrophotometric and electron microscopy laboratories - choosing and installing (including EDX and WDX analysers), undertaking research and ... See full profile

Surrey, United Kingdom

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