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Choose the Plan for You
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INCREDIBLE PHARMA CAREER
999₹How to get a job in Pharma industry within 60-90 days- Job Search Strategy
- Job Search Planner
- Create World Class Resume
- Create Incredible LinkedIn profile
- Prepare For Job Interviews
- Interview Checklist, Do's and Don'ts
- Incredible Salary Negotiation
- Attract Opportunities Like a Magnet
- Interview Question Model
- Deep Self Knowledge
- Job Communication Toolbox
- Incredible Interview Questions
- Recruiter Outreach Strategy
- Resume Architecture
- Best Value
QUALITY MASTERY CHALLENGE
8,990₹Perfect for experienced pharma professionals to achieve exponential career growth- Job Search Strategy
- Job Search Planner
- Create World Class Resume
- Create Incredible LinkedIn profile
- Prepare For Job Interviews
- Interview Checklist, Do's and Don'ts
- Incredible Salary Negotiation
- Attract Opportunities Like a Magnet
- Interview Question Model
- Deep Self Knowledge
- Job Communication Toolbox
- Incredible Interview Questions
- Recruiter Outreach Strategy
- Resume Architecture
- Top Skills for the Pharma Industry
- Power of ICH Guideline
- Fundamentals of Stability Study
- Fundamentals of Method Validation
- Impurities in Drug Substances
- Impurities in Drug Products
- Residual Solvents in DS & DP
- Basic QMS (Change Control, Incident, OOS)
- Lab Operations Blueprint
- Concentration Design Formula
- Specification Design Formula
- Instrument Operation Blueprint
- HPLC Method development
- GC Method development
- Dissolution Method development
- Spectroscopy Method development
- Instrument Calibration Mastery
- Instrument Qualification Mastery
- Interview Questions Model
- Mass Spectrometry Blueprint
- Inner Circle Call
- Method Validation Mastery
- Assay method validation Mastery
- Dissolution method validation Mastery
- Related substances method validation Mastery
- Statistics in Analytical Chemistry
- ICH Quality Blueprint
- Cleaning validation blueprint
- Extractables & Leachables Blueprint
- Stability Study Mastery
- IVIVC Blueprint
- QMS Mastery (OOS, OOT, Change Control, Incident, CAPA etc.)
- Mutagenic & Nitrosamines Blueprint
- Impurity Management blueprint
- Information Technology Blueprint
- Pharma tech blueprint
- Concentration matrix design
- Calculation formula design
- GMP & GLP Blueprint
- CSV Blueprint (as per ISPE's GAMP-5)
- FDA 483 Observations Blueprint
- Six Sigma Blueprint
CAREER ACCELERATOR PROGRAM PHARMA MFG
4,999₹Perfect for freshers and beginners to achieve exponential career growth in pharma manufacturing- advanced certification in pharmaceutical manufacturing
- incredible pharma career
CAREER ACCELERATOR PROGRAM PHARMA QC
4,999₹Perfect for beginners and freshers to start a career in the Pharmaceutical quality control- Advanced certification in Pharmaceutical Quality Control
- Incredible Pharma Career
CAREER ACCELERATOR PROGRAM PHARMA QA
4,999₹Perfect for beginners and freshers to start a career in the Pharmaceutical quality assurance- advanced certification in pharmaceutical quality assurance
- incredible pharma career
BIOLOGICS & BIOSIMILAR + BONUS
2,999₹QUALITY ASSURANCE
3,900₹EUROPEAN DRUG REGULATORY AFFAIRS
5,999₹UK RUSSIA USA CHINA DRA CRASH COURSE
1,999₹INTERNATIONAL DRA
8,999₹US DRUG REGULATORY + BONUS
5,999₹EU DRUG REGULATORY + BONUS
5,999₹PHARMA CAREER ACCELERATOR
8,999₹BIOLOGICS & BIOSIMILAR REGULATIONS
999₹EU MEDICAL DEVICE REGULATION
999₹- SECTION 1: INTRODUCTION
- SECTION 2: ECONOMIC OPERATORS
- SECTION 3: EUDAMED
- SECTION 4: UDI/REGISTRATION
- SECTION 5: CLASSIFCIATION OF MEDICAL DEVICE
- SECTION 6: CONFORMITY ASSESSMENT
- SECTION 7: SUFFICIENT CLINICAL DATA
- SECTION 8: POST MARKET SURVEILLANCE
CTD & DMF + EU MED. DEVICE+ PV ISO13485
1,999₹- 👉CERTIFICATION IN CTD & DMF COURSE HIGHLIGHTS
- Overview of Common Technical Document (CTD)
- CMC Dossier Preparation and Regulatory Compliance
- eCTD Training
- Practical Training on Dossier Preparation
- Stability Testing for Pharmaceuticals
- DMF Preparation and Submission
- Practical Training on DMF Preparation
- Site Master File (SMF)
- DMF Completeness Assessment
- DMF in Global Perspective
- Effective Management of Dossiers
- Common Mistakes in Dossier Preparation
- ANDA Submission Filing
- Importance of PAS in ANDA Filing
- Case-Based Learning: 505(b)(2) vs. ANDA Suitability Petition
- Case-Based Learning: NCE vs. 505(b)(2) Application
- Case-Based Learning: FTF vs. 505(b)(2)
- Case-Based Learning: 505(b)(2) Filing
- 505(b)(2): Mitigating 30-Month Stay in ANDA Filings
- Country-Specific Stability Zones
- Stability Data
- Bracketing and Matrixing
- PK/PD in Drug Discovery
- Bioequivalence Study and Designs
- Biopharmaceutics Classification System (BCS)
- Bioequivalence and Dissolution Data Submission
- Generic Drug Approval and Additives Labeling
- Variation Management and Classification
- Regulatory Requirements for Biosimilars
- CMC Writing Checklist
- Comparison of DMF Requirements of Various Countries
- Comparison of ICH, US & EU CTD Requirements
- 👉CERTIFICTAION IN EU MEDICAL DEVICE REGULATION HIGHLIGHTS
- Introduction to medical Device Regulation
- Why Change in Medical Device Regulation
- Timelines for Implementation
- Economic Operators
- European Authorized Representative
- Distributor, Importer, Manufacturer,
- Procedure Pack & System Provider
- Obligation Change
- Person Responsible for Regulation Compliance
- Introduction to EUDAMED
- EUDAMED: Actors Registration & Timelines
- Introduction to UDI
- UDI Part 2 & 3 and Timelines
- Classification of Medical Devices
- Qualification of Medical Devices
- Definition of Medical Devices
- Rules of Medical Device Classification
- Applying the Rules of Medical Device Classification
- Conformity Assessment for Class I Medical Device
- Conformity Assessment for Class Im, Is, Ir Medical Device
- Conformity Assessment for Class IIa Medical Device
- Conformity Assessment for Class IIb Medical Device
- Conformity Assessment for Class III Medical Device
- General Safety & Performance Requirements
- The Intended Purpose
- Clinical Evaluation
- Post Market Clinical Follow Up
US DRA + LATAM DRA
1,999₹EU, JAPAN, GCC & MIDDLE EAST DRA
1,999₹CTD, DMF + QbD + AQbD
1,999₹METHOD VALIDATION PACKAGE
1,999₹
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