ALSAnalytical
IND-01 · Pharmaceutical & Biotech

Data your regulator has seen before.

We serve API manufacturers, CDMOs, and clinical-trial supply teams that need independent analytical data in a format regulators already recognise — ICH-referenced, USP-formatted, signed by an authorised signatory.

§ 01 — What buyers ask for
Q-01

Elemental impurity dossiers

Full ICH Q3D risk-assessment support with PDE comparison and route-of-administration flags.

Q-02

Second-source verification

Independent purity and identity on incoming API from a new supplier or contract manufacturer.

Q-03

Stability for submission

ICH Q1A(R2) programmes with pre-defined pull schedules and shelf-life extrapolation per Q1E.

§ 02 — Services we typically run
§ 03 — Reporting conventions

Formatted the way your buyer reads it.

  • CoAs reference USP / Ph. Eur. / JP compendial methods where applicable
  • Elemental impurity reports include ICH Q3D PDE comparison table
  • Raw data retained 5 years, exportable in eCTD-compatible PDF/A
  • Chain-of-custody log attached — receiving to release, timestamped
  • Signatory qualifications available on request for regulator queries

Talk to us about your submission.

IntakeArrow the compound, quantity, and target market. We reply with a scoped quote in one business day.