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Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), USA

Expert in Pharma Analytical Development, Stability, and QC Lab operations
Extensive use of various analytical techniques for qualitative and quantitative evaluation of small and large molecule compounds. Written many procedures describing in detail how the technique works and how it is to be used with various sample matrices. See full profile

Illinois (IL), USA

Expert in Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing the ... See full profile

Brussels, Belgium

Expert in Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument ... See full profile

Massachusetts (MA), USA

Expert in Pharmaceutical, Nutraceutical & Cosmetic Manufacturing
Expert has extensive experience with the Pharmaceutical, Dietary Supplement and Cosmetic manufacturing processes. Expert has been most efficient in providing compliance, process optimization and cost control guidelines through documented implementation. See full profile

New Jersey (NJ), USA

Expert in Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. See full profile

California (CA), 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 QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. See full profile

California (CA), USA

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 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 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 Engineering Maintenance, Calibration, Training, Safety System Implementation & Audits
As he has been the Head of Facility & Chief Engineer & Administration of world class standards,he was overall in charge of Facility Management of Medicorp's as well as Unit I & VI. Of Aurobindo's world class manufacturing facilities complying with ... See full profile

AP, India

Expert in Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design, ... See full profile

Massachusetts (MA), USA

Expert in Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP's/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international ... See full profile


Expert in Pharmaceutical Drug Development, Strategic Executive Management, Biopharma Mergers and Acquisitions
Expert has over 20 years of experience. He is extensively active and has significant experience and expertise in Europe and the US in the areas of drug development and financing throughout Europe and the US. He was responsible for the overall ... See full profile


Expert in FDA Regulatory Affairs, Compliance and Submissions
Expert is a former FDA reviewer with two decades of industry consulting experience in the following areas: GCP/TMF auditing, SOP writing, regulatory affairs, clinical development, submission preparation for drugs and devices, SAS programming, Part 11 ... See full profile

Maryland (MD), USA

Expert in Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a PhD in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and ... See full profile

New Jersey (NJ), USA

Expert in Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an Internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near infrared and multivariate analysis. See full profile

Maryland (MD), 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 Clinical Laboratory Testing, Interpretation, Quality Assurance and Reporting.
Expert was trained in clinical chemistry and toxicology and is a Fellow of the American Board of Clinical Chemistry, Academy of Clinical Biochemistry and has over 19 years experience directing clinical laboratories including forensic (drug testing) ... See full profile

Colorado (CO), USA

Expert in Phytochemistry, Ayurvedic Dosage Forms, Ayurvedic Panchakarma
He is a leading Phytochemist in Mumbai. He has a unique combination of working as Phytochemist, Analyst, Organic Synthesis & Ayurvedic Panchkarma Expert. He has developed more than 25 new and 13 generic formule for Ayurvedic remedies. See full profile


Expert in Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science ... See full profile

Florida (FL), USA

Expert in Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, ... See full profile

Virginia (VA), USA

Expert in Carbohydrates, Biopolymers, Glycobiology, Biotechnology, Food, Biomedical, Gum
He has many years experience in the area of thickeners and hydrocolloids. His Ph.D was on the Chemistry and Enzymology of Carrageenans and other biopolymers and he worked for several years on the development of xanthan gum and other biogums of commercial ... See full profile

Berks, United Kingdom


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