Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

Senior Pharma Regulatory Consultant with Expertise in Strategic Planning, Development, US Regulatory Preparation, Documentation (IND ANDA, DMF, CTD) and Quality AssuranceExpediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.Building pharmaceutical regulatory departments and assessing their effectiveness in paralle...

Transitional Medicine-Protein Therapeutics and Nanobiotechnology Focusing Alzheimer’s, Brain Trauma & Cancer Through Drug Development, Nanoparticle based targeted-drug delivery of chemotherapeutics an  Recombinant antibodies (scFv, Fab), immunotoxins and antibody-drug conjugates (ADC), targeting characterization and pre-clinical testing in animal models. Expression, purification and characterization of biotherapeutics and testing in cancer xenografts in mice. Combinatorial phage library screening in disease models of cancer, brain diseases (Alzheimer’s, Traumatic Brain Injury) and drug-resistant bacterial infections. Transit...

Global Ph.D. Biopharmaceutical Analyst Expert: Lean Manufacturing, Program Management, Validation and QualificationCreating lean analytical departments with significantly improved efficiency and turn-around-times. Organizational effectiveness and culture improvementStrategy and execution for concurrent large-scale projects.Biologics (large molecules); small molecule development and analytical development.Research and development executive management; project program management and validation and qualification.CAPA; investigations; drug product development and transformational leadership.CMC expertise: IND, BLA, NDA, 510K, PMA, ANDA, qu...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Organic Chemist in Pharmaceutical Development and Quality Compliance, with Biopharmaceutical and Medical Device DevelopmentPharmaceutical development and quality compliance.Biopharmaceutical and medical device development.Development of pharmaceutical activates related to controlled release drug elute stent medical devices.Contract Service Provider (CRO) management.API development, vendor selection and CMC submission.Bioanalytical method development, validation and testing.Regulatory requirements and compliance, identify pathway, development strategy, define scope and preform gap analysis.Regulatory submissions and preparations (IND, amen...

Analytical Chemistry Consultant Specializing in Drug Stability and cGMP, FDA, and ICH Quality and ComplianceManage pharmaceutical commercial internal-external stability programs providing, guidance for laboratory investigations, input for laboratory information management systems, support sample management programs, and support data review. Provide support to Operational Excellence Projects.Ensuring stability studies are conducted to support regulatory commitments.Communicating trending stability data from the QC laboratory and contract laboratories.Drug stability program management for development and commercial products.Statistical anal...

Drug-Development Expert (Pre-IND to Marketed Products), Pharmaceutical Development Strategy, Regulatory (Domestic and European)Full spectrum of drug development; (pre-IND to marketed products) and development of multiple pharmaceutical products.Global regulatory challenges in drug development and handling a wide range of drug development.Regulatory strategy and CMC strategy.Gap analysis and review of the CMC package.IND and pre-IND submissions.Pre-IN, IND, (Investigation New Drug), CTA, (Clinical Trial Approvals), IMPD, (Investigational Medicinal Product Dossier), NDA (New Drug Application) and MAA (Marketing Authorization Applications) s...

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...