Pharmaceutical GMP Consultant with expertise in GMP, QMS, Documentation, Validations, Plant setup, Training and development, Quality control, Audits, environmental monitoring, for Solid orals, Liquid Sterile, solid orals, liquid orals, dermal products; various dosage forms. Managing strategic and operational performance of Quality Department providing: Development and implementation, Standardized quality system processes, Review of standards for quality control, Regulatory compliance, Quality control systems and procedures (GLP). Pharmaceutical industry (Formulations). Quality Management System (QMS); Complaints, recalls, deviati...

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...

Pharmaceutical Regulatory Consultant with Broad SNDA, GMP, API Development Experience.Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.Major process SNDAs for ofloxacin and leucovorin calcium.Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thiogu...

cGMP Auditor and Expert in Chemistry Pharmaceutics (cGMP 21CFR 210,211,820, ICH Q7A), Mock Audits, GAP Analysis. Pharma and Medical Device Industries.Auditing cGMP 21CFR 210,211, cGMP 21CFR 820, and ICH Q7A.Consulting for Gap Analysis USFDA and other audits.Medical device international consulting.Conducting and organizing trainings and seminars related to Pharmaceutical and Medical device industries.Expert Witness ExperienceCompiling the U.S. norms for a warehouse located in Bhiwandi, IndiaConsulting of Pharma Company for facing USFDA Audits.

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...

Designing, Commissioning, Qualification and Validation in the Pharmaceutical IndustryPharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.Quality assurance and the standards regulations requirements for the pharmaceutical industry.MethodologyRisk Analysis (AMDEC, HACCP)Six SigmaTechnical ExecutionPharmaceutical quality assurance and the standards regulations requirements.Design, quality, commissioning and qualification documentation of pharmaceutical processes.FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.Aseptic pro...

Radiopharmaceutical Consultant Specific To: QA, QC, GMP, GMP internal Audits, Health Canada GMP Inspections and ExpertRadiopharmaceutical industry experience ranging from, Quality Assurance, (QA) Quality Control (QC), Good Manufacturing Practice (GMP), GMP internal audits, Health Canada GMP inspections, deviation handling and implementation of Corrective and Preventative Action (CAPA), change controls stability program, and validation. Oversee fast-paced radiopharmacy production environment. Quality Assurance Manager, applying over15 years of global experience in the radiopharmaceuticals industry. Demonstrated extensive and consistent...

Pharmaceutical: Drug Development and Deliverables, Project Management, Global Clinical Researcher, Medical Writing in Various Platforms, Provide Drug Product Reviews and Statistics ConsultingPharmaceutical development and deliverables: Print modules, slide decks, annotated prescribing information, storyboards for digital media for use in the training of sales force and medical science liaisons. Medical literature identification and interpretation, clinical studies, therapeutic guidelines, prescribing Information, and market research. Drug products evaluation, drug statics and author of technical medical reports. Project proposals and...

Analytical chemist expert in development, validation and transfer of methods for pharmaceutical regulatory filings such as IND, ND, NDA, eCTDSeparation science HPLC, ion chromatography, chiral HPLC, GCAnalytical method development and validation analytical method technical transferLaboratory equipment and instrument qualification and calibrationDesign and setup of GMO and GLP Analytical LaboratoriesRaw material and drug substance characterizationPhysical chemical characterization and structure elucidationProject management for bioanalytical and analytical laboratoriesBioanalytical method developmentQuality assurance for GMO and GMOP labora...