RegulatoryPro's principal consultant, Robert Michalik, has direct "hands on" experience in designing, developing and characterizing a wide variety of FDA-regulated products, including small and large molecules (active pharmaceutical ingredients), finished drug products, cell & tissue therapeutic products and medical devices.   Specific experience gained through his 20 years of experience in biotechnology, pharmaceutical and medical device industries include:

Large Molecule Drug Development - Peptide & Protein Chemistry

• Synthesis and characterization of peptides and polypeptides

• Characterization of native and genetically engineered proteins

• Design and development of pilot-scale and large-scale (commercial) protein purification schemes

Cell Culture & Human Tissue-based Products

• Native and genetically-engineered primary cell line, Master and Working cell bank development, characterization and validation

• Large-scale cell culture operations management

• stem cell & undifferenciated cell therapy technology (allogenic and autologous therapy)

Small Molecule Drug Development

• Chemical synthesis and characterization

Medical Devices

• Class II and III medical device development strategies including

  • design control methodologies,

  • worldwide regulatory strategies and submission preparation

  • Clinical study design, protocol development, GCP compliance and legal/liability issue management

  • post-marketing surveillance and vigilance system development and implementation