INNOVATIVE SERVICES FOR STARTUPS
NuEra is committed to providing quality service and deliverables for startup organizations awaiting approval of their first product.
We understand the issues that startups face including limited resources, newly hired staff and condensed timelines. We are well versed on what the FDA expects organizations to prepare for launch of new products and can assist in a smooth and timely launch.
It is really never too early to begin working on those areas critical to the successful review and approval of promotional materials, but at a minimum, we recommend starting at least 6 months prior to expected approval of the compound. Below are just a few of the ways we can help you grow...
Marketing Material Review Process - An FDA Requirement:
We will develop your framework for a compliant, efficient and expandable review process for Marketing materials and you will be up and running in less than 3 week.
Step 1: Develop Review Process using NuEra’s Rapid Assessment. Leads to faster development and completion of a compliant process. Often includes a short session to work through draft process map with participants.
Step 2: Draft Review and Approval Policy and Standard Operating Procedures (SOPs): This helps establish company standards and guidance… ‘ground rules’ for review. SOP’s reflect new policy and process while clearly defining roles/ responsibilities.
Step 3: Conduct Training and Certification. All participants involved in the review process must be trained and certified on the new policy, SOP’s and process. NuEra can prepare materials and facilitate training or train-the-trainer to deliver.
Resources you can utilize on a short or long term basis:
Reduce Cost and Keep Headcount Low
We have a network of highly experienced affiliates who can fill in gaps when you need them most. We manage and oversee our personnel freeing up your time. Areas of specialty include
Marketing Strategy including launch
Promotion project managers
Reviewers to fill gaps on your team (Medical, Regulatory, etc)
Submission of all OPDP 2253 requirements on your behalf:
Free Up Your Resources
NuEra utilizes an all electronic process for 2253 submissions with 48 hour turnaround. If you are using a review ‘system,' we can assist with submissions through the eCTD gateway.
Mentoring with NuEra’s ‘Trusted Advisor’ Program:
Learn from Experts
Our group of Subject Matter Experts in Promotion Management, Marketing, Regulatory Strategy and Leadership can serve in an advisory capacity on both tactical and strategic issues for the launch of the first product and beyond providing assistance with enhanced business decision making, business agility and continuous improvement.
Skill-set training for new and/or experienced staff
NuEra has access to content experts well versed on Industry PRC best practices – Sessions can be conducted onsite or via webX. Examples of currently available topics include:
Best Practices in MLR Review
Social Media Guidance and current practice
Review Team Expectations
We are always interested in building our library of topics and can work with you to customize a program based on your needs/interests.