Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.

Dosage From Pharmaceutical Consultant: Facilities Management and GMP ComplianceFormulation and process development of multiple types of pharmaceutical dosage forms.Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.Scale up and technology transfer of multiple dosage forms.Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.Identifying and implementing significant operational cost savings in pharmaceutical operations.Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinica...

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...

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,...

Medical Device Consultant (In-Vitro Diagnostics - ISO 13485, 510k, De Novo, CE, CFR 820) with International Experience in Consulting, Program/Project Management, and Manufacturing510k submissions in medical devices.New business and PMP skills managing multiple international projects.Technical proficiencies and strategic planning to optimize existing products and develop new IVD assays.Risk management: Providing risk management assessments, FMEA - design and process, and developing risk management protocols.Composing and documenting product requirements specific to FDA, CLSI, ISO and CE regulations.Technology transfer.Regulatory activities...

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...

Pharmaceutical Analytical Chemistry Consultant Specializing in Method Development, Method Validation, Cleaning Validation and Verification, Drug Stability and cGMP, FDA and ICH Quality and Compliance.Analytical method development and method validation for small molecule pharmaceuticals.Cleaning validations and cleaning verifications.OOS (Out of Specification) and OOT (Out of Trend) investigations.Stability management.Setting specifications for finished products and API.Project management for CROs (Contract Research Organizations).Formulation development support.Pharmaceutical quality control.Protocol and SOP (Standard Operating Procedures...

Pharmaceutical R&D, Quality Operations and Regulatory Affairs Career Expert: Technical M&A due diligence, cGMP/QSR Compliance - Drug, Device, Combination, Biologics. Consent Decree, Warning Letter, and 483 RemediationChemistry and Manufacturing Controls (CMC).Regulatory strategy; domestic and international.cGMP compliance drug: 21 CFR 210, 211.cGMP compliance nutritional supplements/NSF Certification: 21 CFR 111.cGMP compliance drug device combination: 21 CFR 4.Quality systems regulation: 21 CFR 820, ISO 13485.Merger and acquisitions - 3rd party vendor due diligence.Regulatory filing: pre-submission review, writing: NDA, ANDA, 505(b)(2),...

Pharmaceutical Operations - Small to Mid-Sized Companies, from Technology Transfer through Packaging and Distribution, and with Companies Under Regulatory or Financial DuressLife sciences manufacturing with specific focus to technology services, quality systems, engineering oversite, strategic and tactical planning strategies.Providing supply chain consulting and compliance achieving profitability goals, utilizing Lean Six Sigma.ServicesLean Six Sigma Black Belt.Pharmaceutical manufacturing.Pharmaceutical process engineering.Pharmaceutical continuous improvement.Quality engineering and quality systems.Quality Systems Implementation.Cont...