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.
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]
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
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.
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.