CDMO Services

New or generic molecule API manufacturing process development

Route Scouting and Selection

Process Design execution

Design of Experiments & Control Strategies

Characterization

Polymorph solid state salt study

Technology Transfer

 KSM, API and Drug Product manufacturing

Boundary studies and Critical Process Parameters

Demo batch for manufacturing for Toxicology studies

cGMP batch manufacturing for clinical trials

cGMP Registration batches

cGMP process validation and commercial batches

Dosage forms parental, tablets, capsules and emulsions

cGMP Packaging, Labeling and Storage

Serialization

Compendia Test Method verification

Non-Compendia Test Method Development

Analytical Method Validation

Structural Characterization

Specification Development

Routine Release Testing

Routine Stability Testing

Cleaning validation and testing

Raw Material Qualification & Routine Testing

Formulation development

Parental, capsules, and tablets

Stress studies

Freeze Thaw studies

Broach vial studies

Extractables and Leachable studies

Container closure integrity Test

API Stress and forced degradation studies

R&D batch stability studies

Formulation Development stability studies

Registration batches stability studies

Process Validation batches stability studies

Stability storage for Long-term, intermediate and accelerated storage conditions.

DMF Filing

CMC package

IND/ANDA/NADA/ANADA filings

On-going regulatory filings CBE-30 and MCSRs for commercial products

Adverse Events

Supplier audits and qualifications

FDA audit including PAI audits