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Quality & complianceThe documentation is the deliverable.
Material without a data package is a sample, not a supply. Theertha operates a defined quality management system, and every batch and every method leaves the building with its evidence attached.
Quality is not a checkpoint at the end — it is the deliverable a partner can file, defend and scale.
Every programme runs on one continuous, audit-ready documentation trail — from the first construct to the final batch. That is what de-risks a partner's timeline: not just working material, but data a regulator will accept. Our quality system is designed to make that trail complete, retrievable and defensible.
Standard documentation package.
Exact contents vary by product and programme scope. This is the baseline.
| Certificate of Analysis | Issued per batch, covering identity, purity, activity and endotoxin as applicable to the product type. |
|---|---|
| Method documentation | Development reports, qualification or validation protocols and reports, following ICH-aligned practice. |
| Batch records | Executed records for each production run, retained and available for partner audit. |
| Stability data | Real-time and accelerated stability where the programme scope includes it. |
| Transfer package | SOPs, protocols and training records for technology transfer engagements. |
How quality is governed.
Quality assurance
A defined quality management system covering document control, deviation and CAPA, change management, supplier qualification and internal audit.
Quality control
Release and stability testing executed against validated or qualified methods, supported by orthogonal product characterization.
Data integrity
ALCOA+ principles across records and instrument data — attributable, legible, contemporaneous, original and accurate — with audit trails.
Regulatory support
Submission-ready data packages for US, EU and India markets, with support during partner audits and regulatory queries.
Audit & inspection readiness
Structured, retrievable documentation so partner audits and regulatory reviews move quickly and predictably.
Certification scope, audit history and specific regulatory filings are shared with qualified partners under confidentiality during qualification.
Built for submission.
Data packages structured for the markets you file in — US, EU and India.
Certificate of Analysis
Issued per batch, against agreed specifications.
Batch records
Complete, contemporaneous batch documentation.
Method validation
Validation and qualification reports for analytical methods.
Comparability & stability
Bridging, comparability and stability data packages.
Auditing us? Ask for the pack.
We provide current certifications, a quality manual summary and a facility overview to qualified partners under NDA.