Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

Life Sciences Compliance Consultant Specializing in Quality, Regulatory and Validation covering Medical Device Development and Preparing or reviewing CE Mark, FDA, Health Canada and International Regulatory Submissions, ISO, cGMP and FDA Quality and Compliance, EU Authorized Representative, Internal and External Auditing.-per consultant's requestRegulatory and CompliancePreparing CE Mark, FDA, Health Canada and international regulatory submissions; technical and design file reviews.Design control, new product development, product classification, quality system design, implementation and maintenance to ISO 9001, ISO 13485 (including CMDCAS...

Strategic CMC development and planning of ophthalmic, respiratory, and nasal products. Formulation development of ophthalmic, respiratory, nasal, and dermatological productsStrategic CMC development and planning of ophthalmic, respiratory, and nasal products.Formulation development of ophthalmic, respiratory, nasal, and dermatological products.Manufacturing process development, technology transfer, and scale-up of ophthalmic, respiratory, and nasal products.Extractables and leachables testing planning and execution for ophthalmic, respiratory, and nasal products.CMC regulatory writer: Pharmaceutical development and stability reports; CMC...

Clinical and Legal Nurse Expert Specializing in all Aspects of Medical Device Product Development and Regulatory StrategyProduct development expert in recognition of clinical problems that can generate important medical device solutions that meet or exceed sales expectation.Clinical Research Director for large Maternal Infant Care (MIC) Medical Device Business.Expert in developing claims and regulatory strategy for product development.Patient safety and clinical risk assessment process for MIC portfolio.Risk assessment activities during product development.Planned and directed pre and post-market research projects with more than 60 studies...

Medical Doctor with Expertise in all Phases of the Drug Development Process, Including Medical, Legal and Policy Issues Related to Pharmaceuticals, Devices, and Dietary SupplementsAll phases of the drug development process, including medical, legal and policy issues related to pharmaceuticals, devices, and dietary supplements.Therapeutic areas included asthma, epilepsy, cancer, cardiovascular disease, infectious disease, sleep, depression, and prostate cancer.Drug development initiatives, protocol development, data analysis, review and revision submission materials and manuscripts, safety data review, medical monitoring, and medical review...

Life Sciences Consultant Specializing in Intellectual Property, Marketing, Business Development, R&D, Product Development, Product Evaluation, Manufacturing, and International Sales (Biotechnology and Pharmaceutical Industries)Over 20 years of Life Sciences experience in academia, government and biotechnology and pharmaceutical industries.Scientific discovery, development and marketing knowledge for pharmaceuticals and diagnostic equipment medical devices.Development of novel high-throughput screening products for crystallography, genomic, and proteomic technologies.Development of automated and miniaturized biologic testing kits for nuclei...

Academic Clinical Research and Drug and Biologics Development Experience with Overall Program Development, Individual Trial Design, Execution and Reporting.More than 35 years of both academic clinical research and drug and biologics development experience.Directing overall program development, and individual trial design, execution and reporting.Primary direction of complete drug development programs from IND to NDA that resulted in FDA approval.Complete management and oversight of Chemistry, Manufacturing and Controls (CMC) activities, and nonclinical trials.Complete clinical development activities including clinical trial design protocol...

Regulatory Affairs Consultant Specializing in Chemistry, Manufacturing and Controls (CMC) and Regulatory Strategy for Quality Module 2 and Module 3 of the ICH Common Technical DossierCMC Specialties in Pharmaceutical and Biopharmaceutical IndustriesCMC regulatory strategy, critical review and assessment, related to the content of the drug substance, Active Pharmaceutical Ingredient (API) and drug product quality modules (Module 2: Quality Overall Summary (QOS) and Module 3: Quality of the Common Technical Document (CTD) for regulatory Submissions).Interpretation and application of CMC regulatory regulations and guidances for Investigationa...

Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development; IND Filing, Support of Phase I & II Clinical TrialsSynthetic and medicinal chemistry.The integration of all aspects of drug discovery, from early-stage research in chemistry and biology, through patent protection, pre-clinical development, CMC, IND-filing and support of Phase I and II clinical trials.Indication areas of experience: Inflammation, cancer, neurological and neurodegenerative diseases, age-related macular degeneration, and diabetic retinopathy.18 years o...

Pharmaceutical Statistics Data Analysis and Clinical Trial DesignPharmaceutical bio-statistician.Pharmacokinetics and data analysis for clinical trials.CNS: Schizophrenia, bipolar disorder, Alzheimer's disease, migraine and over-active bladder.CV: Hyperlipidemia, diabetes (novel PPAR y & %u0105, atrial fibrillation, anti-platelet agent.Oncology: VEGFR EGFR inhibitors, lung and thyroid cancer, non-small cell lung cancer, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), advanced solid tumors.Immunology: Malignant melanoma (DNA immunotherapy, hepatitis B and C (PEG-Inetrferon), H5N1 vaccine, RNAactive-derived vaccine (for p...