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Ensuring Compliance for Active Pharmaceutical Ingredients (APIs)

Regulatory oversight for drug substances (Active Pharmaceutical Ingredients – APIs) is critical for drug approvals. Authorities demand stringent quality, safety, and efficacy documentation to ensure patient safety. Proper regulatory support can accelerate approvals and reduce compliance risks.

Alchemy’s Drug Substance Regulatory Services

We provide specialized regulatory support for drug substances to ensure compliance with global regulatory frameworks, including:

DMF/ASMF Preparation & Submission

Comprehensive preparation and submission of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs).

Quality & Stability Studies Documentation

Ensuring compliance with ICH guidelines for stability studies.

Regulatory Gap Analysis

Identifying deficiencies and preparing a roadmap for compliance.

Post-Approval Support

Handling updates, amendments, and ongoing compliance monitoring.

Why Choose Alchemy for Drug Substance Regulatory Support?

  • Global Regulatory Expertise – Skilled in USDMF, EDMF, JDMF, and other regional formats.
  • Industry-Leading Knowledge – Specialized in small molecule and biologic API submissions.
  • Seamless Coordination – We work closely with API manufacturers to ensure full regulatory compliance.
  • Proactive Documentation – Ensuring timely, accurate, and streamlined submissions to reduce delays and risks
180

DMFs filed

60

APIs Handled

0%
Regulatory Compliance
20

Global Audits Passed

Testimonials

Voices of Trust

“Thanks to Alchemy, we successfully registered our API in multiple markets with consistent documentation.”

Synthokem Labs

RA Executive

“Their DMF preparation and submission support helped us meet strict timelines for our client partners.”

Nefrosyn APIs

Global Regulatory Lead

“Alchemy’s expertise in CEP and ASMF requirements was pivotal during our EU expansion.”

Granitex Chemicals

Quality Compliance Head

“From impurity profiling to QOS writing, their documentation quality was outstanding.”

BioAxis Organics

Documentation Manager

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