I’m familiar with ICH E3, ICH M4, ICH E6, as well as FDA and EMA guidelines. By collaborating closely with your team, I ensure that all documentation meets stringent regulatory standards.
Whether it’s writing CSRs, developing IBs, or preparing CSPs, I am committed to high-quality deliverables that facilitates successful regulatory outcomes.
My goal is to support biotech, pharma, CROs, and medical device in navigating the complex landscape of regulatory documentation. I aim to expedite your approval process and contribute to the advancement of innovative therapies by ensuring that your submissions are meticulously prepared and aligns with current regulatory guidelines.
Each regulatory submission I’m privileged to work on has successfully navigated the rigorous review processes of health authorities, ensuring timely approvals. By engaging my services, you are assured of meticulously prepared documents that not only meet stringent regulatory standards but facilitates smoother pathways to market.