cGMP Auditing, AMP; Compliance, CMC Preparation, Veterinary Drugs, Product Formulation, Software ValidationcGMP audits & amp; compliance evaluations, CMC document preparation, product formulations & design, package development, software validation, veterinary drugsExpert in: cGMP audits and compliance evaluations, CMC document preparation,product formulation and design, chemical supplies management, contractor management, package development, software validation, and veterinary drugs.Rebuilding businesses, restructuring organization and moving into new manufacturing facility.Built quality systems, rewrote SOPs, designed and implemented...

Experienced in Target Validation and Lead Discovery Through Nomination of Compounds for Preclinical Development and due diligence evaluation for in-licensing opportunities.Drug Discovery: Target discovery and validation, assay development, High-Throughput Screening (HTS), hit-to-lead and lead optimization.In vivo pharmacology: Disease modeling, neurodegeneration and neuroscience, efficacy testing, biomarker discovery.Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD).Project management.Laboratory design and streamlining laboratory operations.Business: Strategic planning and decision matrix evaluation, scientific due diligence, I...

Experience in domestic & international pharmaceutical research, development and general management of ethical & OTC pharmaceutical products and technologyThirty years of experience in domestic & international pharmaceutical research, development and general management of a broad range of ethical and OTC parmaceutical products and technology.Strong goal orientation, effective communication skills, proven track record, and bottom-line accountability.Significant contributions to business-wide strategic goal setting, improvement processes, outsourcing, and vendor selection.

DABT Toxicologist and Scientist with Applied Industrial Experience Specific to IND and NDA Submissions to the FDA and Global Equivalents.DABT Toxicologist and Scientist, Department Head with over 12 years applied industrial experience, supporting and directing interdisciplinary teams to both IND and NDA submissions to the FDA and global equivalents.Management, budgetary and scientific skills include discovery, investigative, and regulatory drug safety assessment with an excellent foundation in toxicology, pharmacology, physiology, biochemistry and DMPK.Therapeutic areas supported are anti-infectives, cancer, immune regulation, diabetes, CN...

Experienced biostatistican to support pharmaceutical data analysis in drug development, efficacy screening and clinical trials.Statistical AnalysisProtocol Development - Pharmaceutical, Biotech, Medical Device, NIHPharmacokinetic (PK) AnalysisSAS ProgrammingStatistical Report WritingData and Safety Monitory BoardSensitivity Analysis2002 - Present Independent ConsultantStatistical services to the pharmaceutical, biotech, and medical device industries and the National Institute of Health (NIH).Statistical services...

Drug safety and medical director with experience in cardiovascular, endocrine/metabolism, anti-infective and dermatological productsClinical development and drug safety, epidemiological and outcomes research, business development and product acquisitions of 30 years with a variety of clinical practices.Physician practice includes: Pediatric and general medicine ICU/NICU, ward, emergency room, clinics, and research center management.Global pharmacovigilance ranges across all therapeutic areas of drug development, including but not limited to: cardiovascular, anti-infectives, metabolism and endocrinology, oncology, respiratory and allergy, v...

Consultant for drug development for cardiovascular therapeutics and heart failure; experienced as an expert witness.Drug development, specializing in cardiovascular therapeutics.Expert witness and the evaluation of cardiovascular drugs.Drug safety.Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).Product support-promotional review and medical information.Evaluation of previously monitored clinical studies.Principal Investigator in the following areas:Vasodilator and inotropic drugs.Vasodilator therapy for acute myocardial infarction.Nitrates and hydralazin...

Neurobiologist Consultant: Central Nervous System, Spinal Cord Injury, Hemostasis, Thrombosis and Autoimmune DiseasesEight (8) years of experience in biotherapeutic drug discovery and development with a focus on neurobiology, hemostasis, thrombosis and autoimmune diseases.Drug discovery research for hemophilia and in critical bleeding indications.Development of therapeutics for spinal cord injury, multiple sclerosis and other central nervous system disorders.Experienced with molecular and cellular pharmacology, cell-based assays with central nervous system (CNS) and immune cell types, immunohistochemistry and thrombosis pathology, animal m...

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...