Increase program success

Regulatory approval procedures are becoming increasingly stringent and time-consuming. Not having the right regulatory strategy in place will cost time and money, and may result in the failure or delay of your drug development program.

Increase your program’s chance of expedited success with global program development guidance from seasoned experts from industry and regulatory agencies. Certara’s integrated team of regulatory strategists provides regulatory strategy, consulting, and regulatory submissions support for drug and device development programs from preclinical through late-stage, post-marketing.

Avoid program failure. Proactively partner with a team that will evaluate your program and provide tailored regulatory strategies while ensuring your program’s regulatory compliance with maximum efficiency. Custom partnership models are available to provide flexibility and allow for personalized support, as needed.

Deep specialty area expertise

Certara’s experts in regulatory strategy create efficient strategies for drug and medical device development programs in major global markets in a wide range of therapeutic and specialty areas, including:

  • 505(b)(2)
  • Biologics and biosimilars
  • Rare/orphan diseases
  • Expedited programs
  • Emergency use authorization
  • EU MDR/IVDR submissions
  • Clinical and performance evaluations
  • 510k clearance and pre-market authorizations

As key opinion leaders, Certara’s regulatory strategists speak regularly at major industry events such as DIA meetings, RAPS Regulatory Convergence, and AMWA’s Medical Writing and Communication Conference.

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Leverage a robust submission strategy

We have proven frameworks and processes to craft the best regulatory strategy, product development and clinical plans to meet your needs.

  • Gap analysis of development programs, global dossiers and regulatory agency correspondence
  • Consideration of expedited regulatory pathways
  • Due diligence assessments for in-licensing and partnering, including proposals to increase value proposition
  • Global submission strategy, preparation and leadership focused on incorporation of regional regulatory requirements [IND/IMPD/NDA/BLA/MAA/510(k)/PMA]
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Expert communication and collaboration are essential

Our experts in regulatory strategy include ex-industry and regulatory agency staff with decades of experience successfully engaging with key stakeholders.

  • Agency engagement preparation, communications and leadership
  • Labeling consultation, preparation and negotiations with regulatory agencies
  • Proactive stakeholder consultation to achieve alignment
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Elaine Taylor Vice President, Regulatory Strategy and Policy

Elaine has extensive regulatory experience and specializes in innovative and efficient regulatory strategies for drug development, including 505(b)(2) programs, regulatory agency meetings, responses to regulatory agencies, INDs, and NDAs/BLAs/MAAs.  Previously, she was at Syneos Health and Camargo Pharmaceutical Services.

Angela Siebeneck, MSN RN Director, Regulatory Strategy and Policy

Ms. Siebeneck has over 30 years of clinical and device experience. She has written and provided guidance and advice for over 100 clinical evaluation reports for a wide variety of devices. During her career as a nurse she gained deep practical experience with many of the types of devices she has developed and implemented clinical evaluation strategies. She has even written a book on peripherally inserted central catheters (PICC) which provides details on how to insert and care for PICCs and ensure compliance with the recommendations for use.

Oxana Iliach, PhD Senior Director, Regulatory Strategy and Policy

Oxana has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. She specializes in global regulatory strategy and drug development for rare diseases, pediatrics, and biosimilars, with a focus on Chemistry, Manufacturing and Control (CMC). She has hands on experience with regulatory meetings and various types of submissions to EMA, FDA and Health Canada.

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