When should I ask for regulatory help?

We are here to help, regardless of where and when you need it. Do you need a strategy to navigate the development and submission of a new product? Are you struggling with achieving a cost-effective and efficient solution that ensures balance between compliance and risk? Are you trying to develop solutions to resolve failures identified internally or through engagement with regulatory agencies globally? With over 100 years of combined expertise, RAS commands a unique understanding of current and emerging trends, ultimately delivering a thoughtful and targeted approach to meet your needs.

  • Strategy Level
    • Regulatory Pathway Strategies
      Whether you are developing a drug, device, biological product, or a combination product, understanding how to navigate regulatory pathways can be difficult. RAS fosters a collaborative environment to understand the type of pre-market submission necessary to market your product in the US (i.e., IND, NDA, ANDA, or BLA) and abroad, with expert knowledge of global product development and marketing requirements for the Americas, Asia-Pacific, and Europe. Our regulatory affairs consulting approach includes requesting, preparing for, documenting, and participating in discussions with regulatory agencies. We offer a range of assistance from responding to inquiries regarding the clinical relevance of safety and/or efficacy data, to preparing for high-profile public event/forums, to engaging with patient advocacy groups, industry watchdogs, your competitors, and even the media.
    • Quality System Design and Gap Analysis
      You want a quality management system (QMS) you can count on. Development should begin with predefined objectives and emphasize a clear understanding of product and process control, based on sound science and quality risk management. RAS can assist you with designing a QMS that exceeds regulatory requirements, helping you beat your competitors to market, or assist with identifying where your company lacks regulatory requirements in its current QMS infrastructure.
    • Inspection Preparedness and Readiness
      As a member of the pharmaceutical and/or medical device community, you have a shared responsibility for ensuring the safety and efficacy of the products your firm designs and manufacturers. Regulatory agencies expect you to ensure an acceptable state of compliance is maintained. Investigators/inspectors are trained to thoroughly evaluate your entire manufacturing/testing operation. Our RAS team can help your staff be prepared to facilitate various types of regulatory assessments.
  • Operational Level
    • Quality and Compliance Audits (GxPs, ISO)
      Increasing GxP audit obligations can lead to qualified resource bottlenecks. Industry- and sector-specific knowledge and understanding affords RAS the ability and expertise to provide regulatory compliance consulting through effectively conducting audits of processes throughout the product life cycle.
    • Pharmacovigilance/Safety and Adverse Event Reporting
      Now that you have marketed your drug product, the next step is maintaining a robust process for the collection, detection, assessment, monitoring, and prevention of adverse events. Knowing the process to report adverse events to regulatory agencies is a communication pathway that is essential to not only maintaining compliance, but also protecting the patients who use your products.
  • Remediation Level
    • Quality and Compliance Remediation
      RAS is a team of professionals who advocate for your ultimate success. As each situation is different, we must evaluate each instance objectively, identify its unique opportunities and challenges, and devise an approach that addresses challenges as quickly and efficiently as possible. We have experience developing and implementing sustainable QMS remediation strategies that effectively and efficiently address issues identified through internal/external audits and regulatory inspections.
    • Product Recalls
      Comprised of ex-regulators and compliance professionals, RAS serves as a resource for understanding, implementing, and/or documenting a product recall, including how to properly and promptly manage it (including alerting the public), safely correct/remove the affected product, and effectively monitor all associated activities.
    • FDA 483 and Warning Letter Responses
      Knowledge of global product development, manufacturing, and marketing requirements for the Americas, Asia-Pacific, and Europe fosters unbiased development and review of inspectional responses to findings/observations (i.e., FDA-483) and/or warning letters that clearly communicate how the issues identified will be corrected. RAS provides a team that is experienced in the review and evaluation of regulatory responses, reassuring regulatory agencies that the product or practice in question is safe and effective.

Additional Areas of Expertise Include:

  • Supplier/vendor controls and quality agreements
  • Labeling and promotional material review
  • Liaise with regulatory agency and monitoring authorities
  • Regulatory intelligence
  • Pre-market and post-market risk/benefit analysis

How can we Support your Program?