Custom Synthesis Solutions
Tailored Chemistry. Trusted Partnerships.
Comprehensive Development and Manufacturing Support
We provide end-to-end development and manufacturing support to global generic and innovator companies , covering the complete product lifecycle from early-stage route scouting and process development to scale-up, commercial manufacturing, and support regulatory submissions.
Integrated development and manufacturing for generics and innovators:
From route scouting to scale-up
Commercial manufacturing & regulatory submissions
Strategic long-term partnership
Our Process:
Tailor-Made Chemistry for Specialised Needs
Pre-Clinical
- Route selection
- Process development
- Analytical development
Phase II
- Solid state characterization
- Quality by Design (QbD) approach
- Determination of critical process parameters (CPP)
- Identification of critical quality attributes (CQA)
Commercial
- Product release & retention
- Lifecycle management
- IP protection
- Extensive batch size range: 0.1 kg to 1,000 kg
Phase I
- Technology transfer
- Analytical validation
- Reference standard & impurity qualification
- Preliminary stability studies
Phase III
- Process validation
- ICH stability studies
- CMC regulatory support
Our Process:
Tailor-Made Chemistry for Specialised Needs
Pre-Clinical
- Route selection
- Process development
- Analytical development
Phase I
- Technology transfer
- Analytical validation
- Reference standard & impurity qualification
- Preliminary stability studies
Phase II
- Solid state characterization
- Quality by Design (QbD) approach
- Determination of critical process parameters (CPP)
- Identification of critical quality attributes (CQA)
Phase III
- Process validation
- ICH stability studies
- CMC regulatory support
Commercial
- Product release & retention
- Lifecycle management
- IP protection
- Extensive batch size range: 0.1 kg to 1,000 kg
Our Goal
At every development stage, our goal is to ensure a robust, safe, and scalable process supported by strong analytical methods and regulatory alignment.
Our Custom Synthesis Strengths:
Phase I
- Robust and safe process
- Route suitability, discrete parameters, impurity control (organic, mutagenic)
- Analytical methods for SMs, IMs, and API; Validation of API analytical methods
Phase II
- Target to select SMs, synthesis route & discrete parameters after Phase II campaigns
- Continued impurity studies, physical characterization, crystallization & milling studies
- Analytical development for SMs, IMs, and API; Validation of API methods
Phase III
- Optimization of process parameters (DoE as needed)
- Critical parameters, NOR & PAR determination
- ICH-level validation of analytical methods
Commercial
- Finalisation of the process
- Process validation & lifecycle management
- Finalisation and validation of analytical methods for SMs, IMs & API
Integrated Infrastructure and Flexible Manufacturing Solutions
Backed by integrated R&D, AR&D, IPM, and GMP manufacturing infrastructure, we deliver customized solutions aligned with customer-specific requirements, timelines, and market strategies. Our multi purpose facilities support flexible batch sizes from grams to multi tons with seamless technology transfer, ensuring smooth progression from laboratory to commercial scale.
Built for Flexibility, Scale & Speed
- Integrated R&D, AR&D, IPM & GMP infrastructure
- Customer-aligned, customized development solutions
- Flexible batch sizes & multi-product operations
- Seamless tech transfer from lab to commercial scale
IP Protection Quality Control Quality Assurance Regulatory Affairs
Robust IP protection frameworks, strong data integrity systems, and confidentiality-driven processes ensure secure handling of customer-owned projects. With a strong focus on quality, regulatory compliance, and cost efficiency, we support filings across regulated and semi-regulated markets while ensuring reliable and consistent supply.
Secure, Compliant & Regulatory-Ready
- Robust IP protection and confidentiality-driven processes
- Strong data integrity and quality-focused systems
- Regulatory compliance across regulated and semi-regulated markets
- Active regulatory support for API documentation & MA approvals
Regulatory Documentation and Market Authorization Support
In addition, our regulatory team actively supports customers with API-related documentation for finished dosage form filings and provides technical assistance required for Marketing Authorization (MA) grant with global regulatory agencies.
A Collaborative and Scalable Partnership Model
This collaborative and scalable CDMO model positions Megafine as a trusted long-term partner, helping customers accelerate development, optimize manufacturing costs, and confidently bring products to global markets.
Strategic Investments for Long-Term Partnerships
We have and continue to consider new investments based on customer demand and well-defined business cases, enabling long-term and strategic partnerships.
Our regulatory support:
- Dedicated regulatory affairs team to assist your submissions
- Regulatory coordination as part of end-to-end project management
- Total quality management ensures document and process compliance
- Strong alignment with EHS standards and global expectations
Regulatory Approvals
