The client required external support three upcoming ANDA submissions. This initially centred around senior CMC expertise to author selected Module 3.2.S.4.2/3 and 3.2.P.5.2/3 sections, however the scope was extended as the projects progressed, typically due to a further squeeze on internal resource against firm business submission priorities.
Regulink was able to supply a senior CMC expert to support these submissions at very short notice. Initially the client needed one FTE to start within 2 weeks. This was met by Regulink, although the project itself was delayed by the client.
Resource experience level: +20 years (self sufficient author)
Skill sets:
Excellent method and validation knowledge with an ability to author sections from scratch (raw data and reports) as well as update existing Modules created for other markets.
Knowledge of US ANDA guidance and confidence in authoring all sections to a very high submission ready status with minimal review and to short timelines
Overall budget:
The overall resource budget increased, starting at approx £50k and increasing to approx £100k due to scope extension
The deployment of the senior CMC expert was very successful.
As well as meeting the highly challenging deployment expectation (2 weeks), all three ANDA projects were completed on budget.
All three projects suffered some deadline slippage, but this was due to challenges from the client side, such as competing priorities, scope drift and delays with data generation and Subject Matter Expert (SME) review/approval.
Typically, Regulink can provide its services with a near-immediate start using its industry leading approach. Contact us to find out more.
"*" indicates required fields
Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list. Although not an exhaustive list, the main areas of our expertise and services are shown below:
Regulink provides pharmacovigilance services tailored to support your business needs. Our UK-based in-house QPPV has extensive experience from working as an EU and UK QPPV, with demonstrated leadership and management of large PV projects and teams of PV officers. We understand that all projects and clients are unique, so as with Regulatory Affairs, we offer a fully flexible service and work closely throughout to ensure your requirements are always met. The main expertise and services provided are shown below:
Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.
Read our expert’s thoughts on industry news and regulatory topics.
Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.”
Regulink provides specialist consulting and support services in all areas of regulatory affairs, CMC, pharmacovigilance and project/ programme management to the life sciences industry. We have a broad team with relevant experience in the key sectors of this diverse industry.