Generic Formulation Development Services
Design, optimize, and scale robust pharmaceutical formulations that meet complex regulatory requirements and match reference product performance.
Request Formula Feasibility AssessmentWhat is generic formulation development?
Generic formulation development is the process of designing a drug product that matches the reference product in quality, performance, stability, manufacturability, and regulatory expectations. It includes excipient selection, process design, prototype trials, dissolution optimization, stability evaluation, and scale-up readiness.
Formulation Workflow
From lab-scale development to production readiness — with Engineering Batch as the critical bridge.
Steps 1 – 4
Lab-Scale Development
STEP 01
API & Product Understanding
STEP 02
Prototype Formula Development
STEP 03
Lab-Scale Optimization
STEP 04
Stability & Packaging Check
Up
05
Engineering
Batch
Bridging lab success with real production behavior.
Live
Steps 6 – 9
Production Readiness
STEP 06
Production Scale-Up
STEP 07
Tech Transfer & Validation Support
STEP 08
Commercial Manufacturing Readiness
STEP 09
Manufacturing Troubleshooting
Many formulation projects fail during scale-up — not during lab trials. KH Scientific Solutions helps bridge this critical gap with real industrial experience.
Technical Problems We Solve
From lab-scale trials to commercial manufacturing, we help pharmaceutical teams diagnose formulation and process challenges before they become costly delays.
Dissolution Failure
Inability to match the f2 profile of the reference product across required dissolution media.
Poor Stability
Unexpected degradation or physical changes during accelerated and long-term stability studies.
Assay Variation
Content uniformity or assay fluctuation issues, especially in low-dose solid oral formulations.
Process Failure
Sticking, capping, lamination, or poor powder flow during manufacturing and compression operations.
Scale-Up Risk
Formulas that perform well at lab scale but fail during pilot or commercial batch manufacturing.
Unoptimized Process
We apply QbD and PAT principles to identify critical variables, eliminate unnecessary steps, and build a robust, streamlined manufacturing process.
Key Development & Manufacturing Deliverables
- Active & Inactive Raw Material Specifications
- Manufacturing Formula / Master Formula
- Detailed Processing Instructions with Critical Process Parameters (CPPs)
- Comparative Dissolution & Process Optimization Strategy
- Pilot / Engineering / Commercial BMR Review & Participation
- Scale-Up & Technology Transfer Support
- Process Validation Protocol
- Manufacturing Troubleshooting & Process Improvement
- Finished Product Specifications
Leadership
Technical Leadership Team
Supported by a multidisciplinary pharmaceutical technical team with expertise in formulation development, analytical support, GMP documentation, process scale-up, manufacturing troubleshooting, and commercial technology transfer.
Ahmed Nabil
Founder & Technical Lead
20+ years of hands-on experience in generic pharmaceutical formulation development, scale-up, troubleshooting, and commercial technology transfer across MENA pharmaceutical markets.
LinkedIn ProfileCapabilities
Dosage Form Expertise
Tablets
Compressed solid dosage forms
Capsules
Hard gelatin / filled units
Suspensions
Dispersed liquid systems
Semi-solids
Creams / gels / ointments
Liquids
Syrups / oral solutions
Sachets
Powder / granules
Injections
Vials / ampoules
Who This Service Is For
Our formulation development support is designed for specific challenges at different stages of the generic drug development lifecycle.
R&D Scientists
Formulation scientists who need expert guidance on complex dissolution, stability, or scale-up problems affecting development timelines.
R&D Managers
Managers overseeing multiple development projects who need additional technical bandwidth to meet regulatory submission deadlines.
Generic Drug Companies
Companies entering the MENA/GCC generic market needing end-to-end formulation development support for their product portfolio.
Technology Transfer Teams
Manufacturing teams transferring established formulations to new sites who need technical documentation and validation support.
Case Study
Dissolution Failure Resolution: From 42% to 85% f2 Match in 8 Weeks
A generic manufacturer in Egypt had a BCS Class II tablet that consistently failed to match the reference product's dissolution profile across pH 4.5, 6.8, and water media. After 18 months of internal development, they engaged KH Scientific Solutions to resolve the issue.
Our team identified the root cause as particle size specification drift in the API coupled with a suboptimal wetting agent concentration. Through a structured DoE approach, we redesigned the granulation process and optimized surfactant concentration. The client achieved f2 > 50 in all required media and successfully submitted to EDA within the same development cycle.
Submit Your Formulation Challenge
Describe your current R&D roadblock below. Our team will review it and respond with a technical roadmap within 48 hours — no obligation.
