Submissions
As anyone in the life sciences industry well knows, time is money in the drug development market. Gartner estimates that bringing bringing a drug to market 20 days faster can net an additional $5M in a $100M market; $25M in a $500M market. Adoption of eCTD is forcing life sciences companies to rethink their submissions management strategy. One of the biggest tasks is prepping the documents involved in submissions, especially given the exponential nature of many of the regulatory docs needed. Further complicating matters, an eCTD can have thousands of life cycles, often confusing the regulatory group as to which document to replace and which version is correct. Good life cycle management reduces the risk of product recalls and liability suits - visibility that can avert damage to a company's reputation, brand, and market cap. A successful eCTD must capture all life cycle documents, including responses to questions, variations/amendments, renewals, annual reports, and other materials. We can help you with this critical process in a number of different ways starting with an assessment of your state of readiness. Ultimately the goal is to optimize your chances for success with your submission. Consulting services include:
- Assisting you with the transition from paper to electronic while decreasing costs, enhancing productivity and minimizing quality control issues.
- Document mapping to submission sections, tracking of submission documents, and timeline and resource management
- "Best practices" for document generation, management, and preparation for submissions
- In-house needs assessments and process gap analyses
- Staff augmentation, to complete specific tasks required at key stages in the submission process
- Interpretation of ICH guidelines and agency guidance
- And finally, development of business processes and the creation of associated standard operating procedures (SOPs), to help your personnel learn to function independently as you increasingly integrate new technologies into your existing environment
All of these services can expedite your submissions process while increasing the knowledge base throughout your organization. Our regulatory advisors maintain RAC certifications as well as have extensive experience with global submissions -- both paper and electronic, having worked at some of the largest drug companies in the world optimizing submissions success. While many companies cannot keep up with the rapidly changing submissions guidelines and regulations, our advisors make it their business to maintain ongoing dialogue with the FDA to ensure our clients benefit from the latest interpretations of FDA guidelines and best practices.