Services

SERVICES
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Complex problems require simple solutions.

INPERNUM offers clients a broad range of drug development services. INPERNUM can provide you with the aforementioned expertise in a cost effective manner. INPERNUM offers flexible pricing models to meet the distinct needs of each unique opportunity and client.  INPERNUM sets realistic timelines and provides the highest level of service that all clients seek.

Client Customized Products and Services

Pharmaceutical Product Due Diligence / Competitive Landscape Assessments /
505b(2) Regulatory Pathway /
Medical Validation / Clinical Study Design /
Early Drug Development Planning

Medical / Clinical

  1. Therapeutic Area Expert Opinion
  2. Clinical Plan (Ph 1-4) and operational review
  3. Study Designs (endpoints and objectives)
  4. Target Population / Indication Statement
  5. Medical Validation/Feasibility
  6. Clinical Operations Planning
  7. Key Opinion Leader Identification and Management

 

Program/Project Management

  1. GAP Analysis
  2. Integrated Drug Development Plan
  3. Communications Planning / Key messaging
  4. Target Product Profile (FDA compliant TPP)

Global Regulatory

  1. Product differentiation
  2. 505B(1) or 505B(2) regulatory pathway
  3. Global Regulatory Strategy, Planning, and Execution
  4. FDA or EMA Meeting Request and Planning
  5. Pre-IND Mtgs, EOP2, Pre-NDA
  6. IND compilation and submission

 

Risk Management

  1. Risk Management Plan options
  2. Critical Process Review and Assessment
  3. Tracking Variables and reporting (observations/analysis/implementation/reporting)
  4. Questions / Actions / Decisions / Outcomes Matrix

Request for More Information

phone Phone: 919-599-5501
mail Email: info@inpernum.com

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