Expert regulatory guidance and compliance solutions tailored to your pharmaceutical business needs
With a team of highly experienced professionals, we offer comprehensive regulatory services to
pharmaceutical companies, ensuring compliance with national and international regulations.
Regulatory Affairs
Comprehensive regulatory support for pharmaceutical companies, ensuring compliance with national and international regulations.
Process Simplification
Streamline your pharmaceutical processes for enhanced efficiency and reduced complexity.
Quality Consulting
Expert quality consulting services to maintain highest standards in pharmaceutical manufacturing.
Regulatory Audit Consulting
Prepare for and navigate regulatory audits with confidence through our expert guidance.
CGMP Training
Comprehensive training programs on Current Good Manufacturing Practices for your team.
CGMP Auditing
Professional auditing services to ensure compliance with CGMP standards and regulations.
Quality Culture Transformation
Transform your organization’s quality culture with our comprehensive consulting services.
Validation/Qualification
Complete validation and qualification services for pharmaceutical equipment and processes.
Specialized pharmaceutical consulting solutions
Dossier and CTD Compilation
Expert compilation of CTD, ACTD, and country-specific submissions for ASEAN, CIS, AFRICA, GCC and ROW markets, ensuring regulatory compliance.
- Module 1-5 Documentation
- Country-specific dossier preparation
- Quality documentation review
- Regulatory submission support
Plant Setup & Design
Complete plant layout design planning with compliance to regulatory standards, operations management, and audit support.
- Plant layout design
- Equipment specification
- Regulatory compliance planning
- Operational audits
CGMP Compliance
Ensuring Current Good Manufacturing Practice compliance through systematic quality management and regulatory adherence.
- CGMP audits & assessments
- Quality system implementation
- Deviation management
- CAPA system development
Regulatory Affairs
Complete regulatory affairs support from initial consultation to post-approval maintenance across global markets.
- Regulatory strategy development
- Marketing authorization applications
- Variation submissions
- Regulatory intelligence
Training & Development
Comprehensive training programs for pharmaceutical professionals covering regulatory, quality, and compliance topics.
- GMP training programs
- Regulatory compliance training
- SOP development workshops
- Quality management training
At Mitan Pharma, we offer comprehensive contract manufacturing solutions for all dosage forms tailored to meet the specific needs of our valued clients.
Sourcing & Procurement
Strategic sourcing and procurement of high-quality raw materials
Production & Manufacturing
End-to-end production with state-of-the-art facilities
Packaging Solutions
Comprehensive packaging solutions meeting global standards
Quality Control
In-depth quality control and assurance at every stage
Seamless integration into your supply chain, especially for solid dosage forms
Monitoring and optimizing delivery timelines to ensure on-time performance and customer satisfaction
A secure, online collaboration platform for information sharing and project tracking
Custom access controls for partners and suppliers, ensuring data confidentiality and control
To create a productive and profitable outsourcing partnership, solving the complexities of extended supply chains and enabling you to focus on core operations.
20+
Years Experience
500+
Projects Completed
200+
Happy Clients
100%
Compliance Rate
strategy aligned with your
business goals.
guidance and hands-on
support.