What We Offer
PHARMEX is the One Stop Solution for Pharma Industries, Healthcare industries, Graphic designing, Digital marketing & Artificial intelligence, etc.
Pharma Turnkey Project
End-to-end project management for pharmaceutical facilities, from concept to completion. We handle everything from initial planning and design to equipment installation and validation.
- New plant setup as per current regulatory requirement
- Renovation or expansion of existing plant
- R&D setup and DSIR approval process
- Contract testing lab setup, CRO setup
New Product Development
Strategic guidance and support for developing and launching new pharmaceutical products. Our experts help navigate the complex process of bringing new drugs to market.
- Formulation development support and troubleshooting
- Guidance on biostudy design, selection of CRO for BA/BE study
- Scaleup studies and technology transfer activities
- Documentation as per QbD/ICH/current regulatory requirements
Auditing, Gap Analysis, and Compliance
Comprehensive auditing services to ensure regulatory compliance and identify improvement areas. We help you prepare for regulatory inspections and maintain compliance.
- Audit, gap assessment & compliance assistance for all regulatory agency
- Third-party audit, gap assessment & compliance assistance for all regulatory agency
- Third-party audit, vendor audit, internal audit
- Effective QMS implementation
- Effective CAPA writing and its implementation
Regulatory Affairs Support
Expert assistance with regulatory submissions, approvals, and ongoing compliance requirements. We help navigate the complex regulatory landscape across different markets.
- Preparation, compilation and submission of dossier, DMF as per latest country specific guideline
- Regulatory query response support
- Review of dossier, DMF, ANDA documents for regulatory submission
QC/ADL/AQBD/IT Support
Specialized support for quality control, analytical development, and IT infrastructure. We ensure your laboratory operations and IT systems meet industry standards.
- Technical support for any requirements of ADL and QC
- Guidance on analytical method development (AQBD)
- Analytical method validation/verification
- Method transfer activities (from ADL to QC)
- All IT related assistance
Training / Recruitment / Digital Marketing
Customized training programs, recruitment services, and digital marketing strategies for pharmaceutical companies. We help build and promote your pharmaceutical business.
- Industrial training/tour
- Online consultation from senior industrial & academic expert
- Technical training (onsite and offsite)
- Recruitment of skilled manpower
- Graphic designing/social media marketing/artificial intelligence
Regulatory Expertise
Our team has extensive experience with all major regulatory bodies and standards.
Ready to Elevate Your Pharmaceutical Operations?
Contact us today to discuss how our services can help you achieve your goals.