Pharmaceutical Manufacturing Support Services
What is Manufacturing Support in Pharma?
Manufacturing support services refer to the specialized assistance provided to pharmaceutical and biotech companies in managing and optimizing their drug manufacturing processes — from clinical trial material (CTM) production to commercial-scale manufacturing.
Our team provides regulatory-compliant, cost-effective, and high-quality support throughout the manufacturing lifecycle — ensuring your products meet global standards of safety, efficacy, and quality.
Our Manufacturing Support Services
We provide a full range of support services tailored to your product type, development phase, and regulatory market.
1. Technology Transfer Support
Preparation of technology transfer documentation (TTD)
Support for transferring processes from R&D to GMP manufacturing
Coordination between sending and receiving manufacturing sites
On-site and remote tech transfer management
2. GMP Documentation Support
Drafting and review of Standard Operating Procedures (SOPs)
Batch Manufacturing Records (BMRs) and Master Formula Records (MFRs)
Equipment qualification and cleaning validation protocols
3. Contract Manufacturing Organization (CMO) Coordination
CMO selection and due diligence
Technical and quality agreement preparation
Oversight and communication management between sponsor and CMO
Performance monitoring and audit readiness
4. Clinical Trial Material (CTM) Manufacturing Support
Support with packaging, labelling, and distribution of clinical supplies
Coordination with clinical and regulatory teams
GMP compliance and documentation for CTM batches
5. Scale-Up & Process Optimization
Assistance in scale-up from pilot to commercial scale
Process validation planning and execution
Troubleshooting of manufacturing issues
6. Quality & Regulatory Manufacturing Compliance
Gap assessments for GMP compliance
Audit support (internal and external)
Regulatory inspection preparation (FDA, EMA, MHRA, etc.)
Data integrity and documentation controls
Product Categories We Support
Solid oral dosage forms (tablets, capsules)
Injectables (vials, pre-filled syringes)
Biologics & biosimilars
Topicals, ophthalmics, and inhalation products
Advanced therapies (ATMPs, cell & gene therapies)
Global Regulatory Alignment
Our manufacturing support services align with international regulatory frameworks, including:
ICH Q7/Q8/Q9/Q10
FDA 21 CFR Parts 210 & 211
EU GMP Guidelines (EudraLex Volume 4)
WHO GMP
PIC/S Standards
Why Work With Us?
✔️ Experienced technical and regulatory team
✔️ Seamless integration with your manufacturing and QA teams
✔️ Scalable solutions for startups to large pharma
✔️ Audit-ready documentation and process controls
✔️ Timely support for clinical and commercial milestones
📞 Get in Touch
Whether you need support for technology transfer, GMP documentation, or CMO oversight — our team is here to help streamline your manufacturing operations.
📧 Email: [company@shudarsana.com]
🔗 Related Services
Regulatory Affairs
Quality Assurance & Compliance
Clinical Trial Supply Management
CMC Documentation Services
Pharmacovigilance