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Our Service
At DLSL, we’re committed to accelerating your drug product development with our fully equipped CMC laboratory and pilot plant facilities. Our integrated services span the entire development cycle—from early-stage research through to late-phase clinical manufacturing support.
Our Expertise Includes:
Formulation Design Scientist
- Pre-formulation & polymorphic screening
- Fixed-dose combinations, MR/IR tablets, ODTs
- High-potency and specialty dosage forms
Sterile Product Expert
- Aseptic processing & lyophilization
- Terminal sterilization validation
- SVP manufacturing, RABS/Isolator setup
Phase Separation & Colloidal Systems Specialist
- Biphasic emulsions & suspensions
- Rheology tuning for injectable & gels
- Nanoparticle stabilization
CMC Regulatory Strategist
- CTD/eCTD Module 3 authoring
- QbD-based control strategies
- Global regulatory filings (USFDA, EMA, WHO)
Technology Transfer Lead
- Tech transfer protocols & batch scale-up
- Master Batch Records & PQ validation
- Bridging strategy & equipment matching
Stability Sciences Expert
- ICH Zone I–IVb studies
- Shelf-life prediction modelling
- Extractable/leachable studies
Biopharmaceutics Specialist
- CTD/eCTD Module 3 authoring
- QbD-based control strategies
- Global regulatory filings (USFDA, EMA, WHO)
PQS & Data Integrity Champion
- cGMP & ALCOA+ implementation
- Zero-observation audits (USFDA/WHO/EMA)
- Risk-based QMS systems
IPR & Lifecycle Strategist
- 505(b)(2) & FTF pathways
- Patent avoidance strategies
- End-to-end lifecycle & market launch planning
Whether you need expanded capacity, a reformulation strategy, or end-to-end development support, DLS operates as an extension of your lab—offering flexibility, collaboration, and scientific excellence at every stage.