iCretegy is a branch of iPharmaSolution LLC which is the global Pharma business holders and change makers define the future. Our work culture makes iCretegy unique, valuable, and different.
From strategy to execution, iCretegy is offers versatile consulting support for the entire value chain for pharmaceuticals and biopharmaceutical industries.
We Provide Services In Six Segments
- 1. iRegulatoryOperations
- 2. iRegulatoryAffairs
- 3. iTechnicalWorkshop
- 4. iPharmaInnovation
- 5. iLeadershipWorkshop
- 6. iBusinessStrategy
iCretegy also does Humanitarian activities known as iHuman : GIVING > GETTING. I care, You care & Together We Care by spreading the Humanity.- Volunteering our time, effort, and money to support a cause you are passionate about is something you will never regret.
Services We Offer
iRegulatoryOperations
Accelerating and Enabling the Electronic Regulatory Submissions
- End to End Publishing Service for US/ EU Submissions (ANDA/ IND/ NDA/ BLA/ DMF/ SPL).
- eSubmission planning & management.
- Document & Submission level publishing; eCTD lifecycle Management.
- Serves in different region such as EMA, FDA, MHRA, Swiss Medic, TGA, Health Canada etc.
- Establishment Registration, NDC Labeler Code, Drug Listing etc.
- Paper to Non-eCTD electronic submissions (NeeS) to eCTD conversions.
- Training / updates on the ever-changing global Regulatory requirements.
iRegulatoryAffairs
End to End (E2E) Reg Services in Strategy - $Synergy - System Enhancement
- E2E services Regulatory service from original application, Amendment to life cycle management for ANDAs/ NDAs/ 505(b)(2)/ DMFs etc.
- Our "Begin with End in Mind" Strategy helps to accelerate your approval with Minimum deciencies & early launch with continuous improvement.
- Perform Due Diligence (In license & Out license as well as M&A).
- Expertise inprovidingpost approvalregulatory strategy & $Synergy ideas.
- Regulatory writing services to expedite your submissions.
- Quality Audit for USA, Europe and other emerging market.
- Labelling consultation, preparation and submission.
A one-size-fits-all: The Customer is always First & We can always Serve: To provide the highest quality support to our clients across the globe, by making them more productive and successful. Having a wide range of capabilities allows us to support the needs of your company.
No Customer is Wrong: To provide our clients quality service keep ‘integrity’ in mind.
We can always welcome our customer’s in-put and strives to implement until the end results will turn to success.
iTechnicalWorkshop
To enhance best practices in Technical areas using On-Site Workshops & Trainings
- In-person workshop provides the best tools for latest technical areas which mitigate the risk of errors & costly delays to create $Synergy to the company.
- iTechWorkshop helps “Walk to Talk” ideology goes beyond the content at the conferences such as.
- GDUFA III Awareness Workshop.
- FDA Now | Act Now, Stay Informed.
- Innovation - Automation - Digitalization.
- Begin with End in Mind - Quality Filing - Approval on-time & Launch Readiness.
- Integrated Quality Assessment(IQA) Workshop
- NO MAJOR Complete Response Workshop.
- Departmental Annual Meet (Reg. Affairs, Quality, Ops., etc.)
- Introspect on Investigations (Reduce OOS & Human Error).
iPharmaInnovation
Excellence-Innovation & Digitalization: “BE AN INNOVATOR, NOT AN IMITATOR”
- Operation Excellence : Reduce operating costs (COGS) to improve efficiency & profitability.
- Quality Excellence : Improve compliance and First Time Right, minimize OOS & Human Error.
- Digital Excellence : Shift your company gear from current Technology Adopter to In-House Technology Creator.
- Virtual Training Excellence : Complex & difficult to understand topic to be converted into Mascot +2D/3D + AR/VR to enhance attention and training effectiveness.
- R&D Excellence : To optimize product development cost and improving product launch timeline.
- Competitive Excellence : Robotic Process Automation (RPA), Virtual Assistant Bot, Dashboard for CEO, CSO, COO, Quality Dashboard, Project Management etc.
iLeadershipWorkshop
Improve your leadership to enhance Strategic Execution to the Next level
- This is a tailor made leadership module which sharpens leadership skills of existing leaders and cultivate future leaders.
- Learn to Lead Workshop offers custom based programs to fit your company’s specic needs such as.
- 3’S: Silent - Servant - Spiritual Leadership.
- 3’W: “Wisdom2WorkWorkshop” (apply iCT wisdom for your Personal - Professional & Spiritual growth).
- 3’I: “Inspire - Integrate - Innovate”.
- 3’S: Strategy-$Synergy-System Enhancement.
- DEMO®: Diversity + Equity + Mindset = Ownership® (Retention).
- UNITE - ENGAGE - COLLABORATE
- GOOD 2 GROWTH Mindset.
iBusinessStrategy
Strategic Solution, CoGS Reduction, M&A, Portfolio, Product & Business Strategy
- Helps to find your business value chain constraints with adopting novel business models.
- Emerging Markets v/s Regulated markets business strategies.
- Resources Optimization, Cost Assessment.
- Lower company CoGS for maximum profitability.
- Development, Optimization, Integration of Portfolios.
- Strategic Solutions to close In/Out licensing deals, M& A, business analytics.
- Technical Due Diligence, gap analysis report, filing to agency, approval to launch.
- Strategic alliance in Commercial Excellence, Sales and Marketing.