Marian, another of RANA's Qualified Consultants, is a molecular biologist experienced in regulatory affairs and drug development for both biotechnological and traditional pharmaceuticals. Marian's reputation among regulatory pioneers comes from her near-legendary technical expertise and regulatory strategies for biologic drugs in clinical development, preparation and prosecution of technical submissions (PLA, NDA, and IND) for biotech products, parenterals, devices, creams, transdermals, and oral and solid dosage forms. Her standing in the professional community makes her an often-invited participant and speaker in presentations and seminars regarding the alien territory of regulatory affairs. Marian's integrity and experience fit well with RANA's philosophy and our unwavering commitment to clients.