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...

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...

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...

Clinical Research and Medical Affairs Expert Physician (MD) Specializing in Global Drug and Biologics Development Clinical Expertise; Approval of Multiple Drugs in Small Molecules and Biologics.Clinical research and medical affairs physician (MD) specializing in global drug and biologics development, approval of small molecules drugs and biologics.Commercial development, including Clinical Development Plans (CDPs) due diligence, business cases, and marketing support and protocols for Phase I-IV as well as post-marketing studies.Respected authority and resource working with key opinion leaders in a diverse range of pharmaceutical and medi...

GMP, ISO Quality, Compliance, and Audit Expert for Pharmaceutical and Medical DevicesGMP and ISO matters relating to quality control and quality assurance in the medical device, dietary supplement and pharmaceutical industries.Good Manufacturing Practices (GMP), and ISO Certified Lead Auditor.Document control, training, supplier and quality assurance.Auditing, document control, training, supplier and contract quality assurance.Process validation and contractor managementQuality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. Inject...

Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...

Pharmaceutical and Biotechnical Quality Assurance Consultant - Regulatory, GMP, GLP, ISO, ICH, FDA, Drug Development, Manufacturing and Aseptic Processing. PhD Consultant Specialized in New Product Research, Scale-Up, Compliance, Production Development, New Applications and CommercializationPharmaceutical and biotechnical quality assurance.Broad knowledge of GMP, GLP, ISO, ICH, FDA and International regulations.Managing multiple projects and complex priorities.Drug development, pharmaceutical manufacturing and aseptic processing principles and requirements.Focused AreasProduct releaseProduction batch recordChange controlCommissioning,...