About us
Your Drug Development Partner in MENA & GCC
At Know-How Academy, we empower pharmaceutical companies—especially those developing generic and biosimilar products—with expert support across product development, regulatory pathways, and manufacturing readiness. Our mission is to accelerate drug development journeys by combining scientific know-how with regulatory expertise and market insight.
We serve pharmaceutical companies across the MENA and GCC regions, with a special focus on startups and mid-sized firms that seek growth, efficiency, and market access.
Our Core Services for Pharma Companies:
- Formulation Development: Designing robust and bioequivalent generic drug formulations optimized for stability, manufacturability, and regulatory success.
- Analytical Development and Validation: Developing and validating analytical methods to ensure product quality, compliance, and successful regulatory submissions.
- Biosimilar Technology Transfer: Supporting the transfer of biosimilar manufacturing processes with full technical documentation, risk assessment, and regulatory alignment.
- Regulatory Support and eCTD Preparation: Preparing and auditing Common Technical Dossier (CTD) files in eCTD format for authorities such as SFDA (Saudi Arabia), EDA (Egypt), and JFDA (Jordan), ensuring accuracy, completeness, and strategy alignment.
- Scale-Up and Commercial Manufacturing Support: Assisting in identifying CMOs, scaling up manufacturing, and implementing GMP-compliant production processes for market launch.
- Intellectual Property and Patent Strategy: Providing deep expertise in patent navigation, FTO (freedom to operate), and claim analysis to avoid infringement and maximize product lifecycle value.
Training & Capacity Building
In addition to our technical services, Know-How Academy offers specialized training programs tailored for pharmaceutical professionals. Our blended learning approach helps teams gain practical skills aligned with real-world industry challenges, explore our courses.
Our Vision
To become the region’s leading knowledge and service partner for pharmaceutical companies by providing high-impact solutions that transform scientific potential into commercial success.
Let’s Build Your Next Product Together
Whether you're developing your first generic, expanding your biosimilar portfolio, or preparing for regulatory submission, our team is ready to help you navigate every step of the journey with confidence.
Download Know-How Academy Company Profile from HERE.