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Anwaar Naqvi

Anwaar Naqvi

Graduate Research Assistant

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location of Anwaar NaqviMorrisville, Pennsylvania, United States

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  • Timeline

  • About me

    Formulation Scientist at Pii (Pharmaceutics International, Inc.).

  • Education

    • NeuAge Institute

      2023 - 2024
      Certification Regulatory Affairs

      • Processed application to market a new or abbreviated new drug for human use (Form 0356h). A drug was selected from FDA listing of authorized Generics and other required information were collected from DailyMed, Drugs@FDA and Orange Book.• Enlisted challenges, regulatory requirements, documentation and advantages of Tech Transfer documentation with reference to Chemical, Manufacturing and Control (CMC). The information and guidelines were collected from WHO tech transfer guideline… Show more • Processed application to market a new or abbreviated new drug for human use (Form 0356h). A drug was selected from FDA listing of authorized Generics and other required information were collected from DailyMed, Drugs@FDA and Orange Book.• Enlisted challenges, regulatory requirements, documentation and advantages of Tech Transfer documentation with reference to Chemical, Manufacturing and Control (CMC). The information and guidelines were collected from WHO tech transfer guideline website• Exercised to fill Orphan drug designation request form 4035 of an organ drug selected from FDA approved Orphan drug and rare disease information were collected from NIH website. • Executed Protocol Summary and Study Design sections of a case study protocol selected from clinical data database using actual study data and e-protocol tool.• Collated labeling information of a drug selected from FDA listing of authorized Generics using DailyMed and Drugs@FDA websites. Show less

    • New York University - Polytechnic School of Engineering

      2004 - 2006
      Master's degree Biomedical/Medical Engineering

      Activities and Societies: Member of BMES (Biomedical Engineering Society)

    • University of the Punjab

      1991 - 1996
      Bachelor of Engineering - BE Metallurgical Engineering

  • Experience

    • Memorial Sloan Kettering Cancer Center

      Jan 2005 - Jun 2006
      Graduate Research Assistant

      • Priviliged to work with a team of Orthopedic Surgeons, postdoctoral researchers and biomedical engineers to collect and analyze data of an orthopedic research project “Bisphosphate delivery to large segment bone allografts” and drove pilot study to next level of pre-clinical study.• Investigated ovine bone allograft pretreatment strategies of Bisphosphonate (an antiresorptive agent) to minimize bone resorption by working on the following two hypotheses.• Pressurized pumping by using high pressure/vacuum chamber is more efficient method to deliver Bisphosphonate to large segment bone allograft than simple soaking.• Quantitation of bone bound APD (aminohydroxypropylidene) (a bone scanning agent) via non-invasive Tc99m-APD-SPECT technique is a suitable alternative than using a destructive dye technique.• Assisted research team in preparing 25 µm particle size hydroxyl apatite, human, ovine and canine bone powders and measured the particle size density of each bone powder to study the binding kinetics of Bisphosphonate to bone particles. Show less

    • Pii (Pharmaceutics International, Inc.)

      Nov 2010 - Jan 2021
      Formulation Scientist

      • Conducted new API cleaning risk assessment and toxicology study to initiate cleaning validation study.• Composed technology transfer documents comprising formulation composition, process flow diagram and manufacturing procedure for technical services to draft feasibility and CTM batch records.• Documented and reviewed design of experiments, quality by design, clinical trial material batch records, Labeling and Packaging records, standard operating procedures, stability and bulk hold study protocols, tech transfer documentation, ANDA filing and product development reports according to company and ICH guidelines.• Coordinated with Regulatory Affairs in filing ANDAs by providing product development data and also responded FDA deficiency correspondence. • Collaborated with Quality Assurance on investigations, CAPA and change controls as needed.• Chaired with formulation team, project managers, clients, production, analytical, quality control, materials management and regulatory affairs to get faster approval of drug products for marketing.• Ensured good documentation practice across all departments to ensure quality by design approach throughout the product development process. Administered good housekeeping, lab practice and recordkeeping. Show less

    • KVK Tech, Inc.

      Jul 2021 - Oct 2023
      Formulation Scientist

      • Managed to furnish formulation/ process related CMC documents for filing of new products.• Composed and reviewed design of experiments, quality by design approach, batch records, Labeling and packaging records, standard operating procedures, stability and bulk hold study protocols, tech transfer documentation, ANDA filing and product development reports according to company and ICH guidelines.• Coordinated with formulation, production, analytical, quality control and regulatory affairs to get faster approval of drug products for marketing.• Ensured good documentation practice across formulation and production team. Administered good recordkeeping, housekeeping and good lab practice. Show less

    • NeuAge Institute

      Aug 2023 - now
      Student Member

  • Licenses & Certifications