Procedure: Regulatory Intelligence
Country: Global Procedure
Version #: 11/28/2023
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko
ID: GP-PhR-RI-SRC
Category: Pharmaceuticals/MD&IVD/Others
Validity: Until next NRA update
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
SUMMARY
Regulatory Intelligence involves up-to-date gathering, analysis, and interpretation of information regarding regulations and compliance requirements. Strategic consulting involves providing expert advice and guidance to organizations in developing and implementing effective strategies to achieve business goals and objectives in a specific country.
Must-Have Requirements, Recognized Standards, and Certification:
- Executive Summary, MAs in other countries
- Questions, Suggestions and Proposals
Nice-to-have:
- Intellect. Prop. Rights Evaluation see GP-PhR-IP-SR card
Typical Gaps and Deficiencies: Lack of well-defined goals and business development objectives, coupled with insufficient regulatory documentation
Implementation Period: Immediately
Deliverables: Regulatory insights, compliance guidance, and strategic recommendations for informed decision-making
| PHASE | TASK | TASK | START | DURATION | Fee | KPI | ||
| NUMBER | TITLE | OWNER | W/M/Q/Y | in weeks | 3rd Party | Service | State | |
| 0 | In-house Pre-Submission Activity | |||||||
| 0.1 | NDA signing or validation | Executor | week 1 | 1 | ||||
| 0.2 | Contract Closing | MAH | week 1 | 1 | ||||
| 0.3 | Invoice is sent to MAH and paid | Executor | week 2 | 1 | ||||
| 0.4 | SOW is approved by MAH | Executor | week 2 | 1 | SOW | |||
| I | Research, Evaluation and Strategy Development | |||||||
| I.1 | Input information obtaining | MAH | week 3 | 1 | ||||
| I.2 | Risks, deficiencies, gaps in data or studies identification | Executor | week 4 | 1 | ||||
| I.3 | Review and addressing queries | Executor | week 4 | 1 | ||||
| I.4 | Assembling relevant NRA documents | Executor | week 4 | 1 | ||||
| I.5 | Comprehensive Regulatory Intelligence evaluation | Executor | week 5 | 1 | ||||
| I.6 | Development of the strategic plan for MA | Executor | week 5 | 1 | Report | |||
| F | Final Phase In-house Post-Authorization Activity | |||||||
| F.1 | Service Acceptance Certificate signing | MAH | week 6 | 1 | ||||
| F.2 | Final Invoice | Executor | week 6 | 1 | ||||
| F.3 | Final Payment | MAH | week 6 | 1 | ||||
| F.4 | Contract Termination | Executor | week 6 | 1 | ||||
| F.5 | Archiving and limiting access | Executor | week 6 | 1 | Archiving |
Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com