Services

End-to-end solutions for your API needs.

From early-stage development to commercial-scale manufacturing, our integrated services cover the entire pharmaceutical value chain — under one roof, with one accountable team.

cGMPICH Q7ISO 9001 · 14001 · 45001USFDA · EDQM · PMDA ready

What we do

Core services

Click any service to see scale, specs, and what's included.

Capability highlights

Chemistry, scale, and analytical depth.

A modern facility designed for complex, multi-step synthesis — with the analytical firepower to back every claim on the COA.

Quality standards

Built for regulated markets.

Quality isn't a department here — it's how we design routes, validate equipment, and release batches. Every shipment travels with a complete data package.

Process validation per ICH Q7
Full batch documentation & traceability
Stability studies (ICH Q1A) in-house
Vendor qualification & audit programme
Annual product quality reviews
cGMP

Current Good Manufacturing Practice

Manufacturing block operated to cGMP for APIs (ICH Q7) with documented batch records and change control.

ICH Q7

API quality guideline

Process validation, deviation handling, and supplier qualification aligned to ICH Q7 principles.

ISO 9001

Quality management

Site QMS structured around ISO 9001 for documentation, training, and continuous improvement.

ISO 14001

Environmental management

Effluent treatment, hazardous-waste segregation, and emissions monitoring under ISO 14001.

ISO 45001

Occupational health & safety

Behaviour-based safety programme, PPE compliance, and incident reporting per ISO 45001.

REACH

Regulatory readiness

Capability to prepare DMFs (US/EU/JP), CEPs, and respond to deficiency letters for global filings.

How we work

From enquiry to commercial supply.

STEP 01

Enquiry & NDA

Share your structure and target spec. We sign an NDA within 24 hours and assign a project lead.

STEP 02

Feasibility & quote

Route assessment, costing, and indicative timelines delivered within 48 hours.

STEP 03

Lab → pilot

Route confirmation at lab scale, then pilot-plant validation with full analytical package.

STEP 04

Commercial supply

Validated process transferred to the manufacturing block with on-time, on-spec shipments.

FAQ

Common customer questions.

Can't find what you're looking for? Reach out and we'll respond personally within one business day.

Ask our team
We routinely deliver from 100 g (R&D campaigns) up to 2,000 kg per batch on the commercial block. Multi-ton annual demand is supported through campaign scheduling.

Ready to discuss your project?

Our technical team will review your requirements and respond with a tailored proposal within 48 hours.

Request a Quote