End-to-End Technical Support for Generic Pharmaceutical Development
We provide comprehensive consulting and execution support for every stage of your generic product development lifecycle.
Request a Technical AuditWhat pharmaceutical services does Know-How Academy provide?
Know-How Academy provides formulation development, analytical method development, CTD regulatory support, nitrosamine risk assessment, biosimilar technology transfer, scale-up support, intellectual property strategy, reference standards sourcing, and technical troubleshooting services for generic pharmaceutical companies.
The Generic Development Pathway
Product Selection & IP Review
API & Excipient Sourcing
Formulation R&D
Analytical Method Development
Scale-Up & Pilot Batches
Pivotal Stability Studies
CTD Dossier Preparation
Commercial Manufacturing Support
Detailed Service Capabilities
Targeted interventions for specific development challenges.
Formulation Development
Failing to match reference product dissolution profiles or stability targets.
R&D phase generic development requiring formula optimization.
Excipient compatibility study
Prototype formulation report
Dissolution optimization strategy
Analytical Development
Unreliable testing methods leading to assay variation and OOS results.
Preparing for stability studies or method validation.
Method development protocol
Validation strategy
Troubleshooting report
Regulatory Support & CTD
Incomplete Module 3 documentation triggering authority deficiencies.
Pre-submission compilation or responding to health authority queries.
CTD gap analysis report
Module 3 data review
Deficiency response drafting
Nitrosamine Risk Assessment
Lack of clarity on product contamination risks and regulatory compliance.
Meeting regulatory deadlines for risk assessment submission.
Step 1 risk assessment report
Mitigation strategy
Testing justification
Biosimilar Tech Transfer
Struggling to replicate complex biologic processes at a new site.
Transferring a biosimilar product to a local manufacturing facility.
Tech transfer protocol
Analytical comparability plan
Process risk assessment
Scale-Up Support
Successful R&D batches failing during pilot or commercial scale-up.
Transitioning from laboratory scale to commercial manufacturing equipment.
Process mapping
Critical Process Parameters (CPP) definition
Troubleshooting guide
IP Strategy
Risk of patent infringement delaying generic entry.
Early stage product selection and formulation planning.
Patent landscape review
Non-infringing formulation pathways
Reference Standards Sourcing
Inability to procure rare impurity or degradation standards.
Method validation requiring specific analytical markers.
Supplier identification
Qualification protocol support
Technical Troubleshooting
Unexplained manufacturing failures or sudden stability issues in commercial products.
Post-approval routine manufacturing facing quality deviations.
Root cause analysis
CAPA technical review
Reformulation strategy
Confidentiality
Strict NDA protocols for all product data.
Regional Expertise
Deep knowledge of MENA/GCC guidelines.
Practical Solutions
We focus on manufacturable results, not just theory.
Quality Assured
Operated by KH Scientific Solutions.
Services FAQ
Do you offer project-based or retainer consulting?
We offer both. For specific technical issues (e.g., a failing formulation or a specific authority deficiency), we work on a project basis. For ongoing R&D portfolio support, we offer retainer agreements.
Can you assist with products already submitted for registration?
Yes. A significant portion of our work involves rescuing products that have received complex deficiency letters from health authorities, requiring rapid data generation or robust scientific justification.
Do you guarantee product registration?
We guarantee that our technical outputs and dossiers will meet current regulatory standards and guidelines. Final registration approval ultimately depends on the authority's review process and the physical data generated by your facility.
How do you structure technology transfer projects?
We follow a phased approach: initial gap analysis of sending/receiving site capabilities, protocol drafting, on-site supervision of pilot batches, and final report review to ensure a seamless and compliant transfer.
