ISO 9001:2015 Certified Analytical CRO

One-Stop Solution
for Peptides, Biologics
& NBCD Characterization

Comprehensive analytical and biopharma services supporting drug discovery, development, characterization, and regulatory submissions — aligned with global GMP & GLP standards.

Request a Quote Explore Services

WHO & FDA Aligned GMP / GLP Compliant Audit-Ready Documentation End-to-End Analytical Support

25+

Years Leadership
Experience

30+

Years Quality &
Regulatory Expertise

Specialized
Service Areas

100+

Analytical
Parameters

Regulatory Alignment

WHO GMP US FDA EMA CDSCO ICH Q2/Q3 ICH M7

One-Stop Analytical Solution

Iron Complex Drugs — From Core Structure to Clinical Relevance

One platform for structural, paramagnetic, functional & safety assessment of iron complex drugs.

Paramagnetic Characterization

Mössbauer Spectroscopy
Electron Paramagnetic Resonance (EPR)
VSM / SQUID Magnetometry
Raman Spectroscopy

Structural Characterization

Particle Size, DLS, PDI
Zeta Potential
TEM / Cryo-TEM / SEM
AFM
SAXS / XRD
SEC-MALS
AUC (Analytical Ultracentrifugation)
ICP-OES (Elemental Analysis)

Iron Release, Limit & Stability

Labile Iron Assay (FerroZine)
Dialysable Iron Studies
Bleomycin Detectable Iron Assay
Serum Iron Release
Saline & PN Compatibility
Limit Tests & Stability Studies

Hypersensitivity Assessment

Complement Activation Assay
C3a, C4a, C5a
sC5b-9 / MAC (SC5b-9)

Iron Complex Drug

Paramagnetic Fingerprint

Structural Characterization

Iron Release & Stability

Complement Activation

Clinical Relevance

Ferric Carboxymaltose Ferric Derisomaltose Iron Sucrose Developmental Iron Nanomedicines NDA Molecules ANDA Molecules

Additional Services

Comprehensive Analytical & Biopharma Services

From small molecules to highly complex biologics — reliable, end-to-end analytical solutions aligned with global regulatory expectations across 8 specialized service areas.

Analytical & Testing Services

Method development, validation, stability testing, impurity profiling, and elemental analysis. ICH Q2, Q3C, Q3D aligned.

View details

NBCD Analysis & IVBE Studies

Iron paramagnetic characterization, molecular weight distribution, IVBE studies for non-biological complex drugs.

View details

Peptide Characterization

Full-spectrum peptide characterization: MW, sequence, purity, amino acids, higher-order structure, and stability studies.

View details

Biosimilar Physico-Chemical Characterization

Primary structure, HOS, PTMs, purity, isoforms, and stability — complete ICH Q5E / FDA / EMA aligned data packages.

View details

Bioprocess Related Impurities

HCPs, residual DNA, antibiotics, buffer components, process agents — ELISA, qPCR, LC-MS/MS, and SEC-HPLC.

View details

Extractables & Leachables

Protocol-driven E&L studies per USP <1663/1664>, ICH Q3E, ISO 10993 — for pharma, devices, and food packaging.

View details

Nitrosamines & NDSRIs

Ultra-trace detection, structure-based risk assessment, AI calculations, and regulatory submission support. ICH M7(R1) aligned.

View details

Food Testing Services

Microbiological, heavy metals, mycotoxins, pesticides, allergens, GMO, and shelf-life testing. FSSAI, Codex, FDA aligned.

View details

View All Services in Detail

AMICOM Analytics Lab

ISO 9001:2015 Certified Organization

Who We Are

Specialized Analytics Built on Scientific Excellence & Trust

AMICOM Analytics is a specialized analytical and biopharma services organization supporting drug discovery, development, characterization, and regulatory submissions for peptides, biologics, and non-biological complex drugs (NBCDs).

Backed by leadership with 25+ years of scientific and commercial expertise and 30+ years of quality & regulatory experience, we deliver end-to-end characterization ensuring compliance, integrity, and regulatory-ready documentation aligned with global GMP and GLP standards — WHO, CDSCO, FDA, EMA.

Scientific Excellence Advanced tech & validated methods

Regulatory Compliance GMP, GLP, FDA, EMA, CDSCO

Trust-Based Partnerships Long-term, ethics-driven collaboration

Fast Turnaround Rapid, reliable project execution

About AMICOM Meet the Team

25+

Years Combined
Leadership Experience

30+

Years Quality &
Regulatory Experience

Global

GMP / GLP
Aligned Standards

E2E

End-to-End
Analytical Support

Why Choose Us

Why AMICOM Analytics?

Deep scientific expertise, ethics-driven partnerships, and regulatory excellence — consistently delivering quality outcomes for pharma and biotech clients.

Quality-Driven Precision

Accurate, compliant, and reproducible analytical results using validated scientific methods — data integrity at every step. All analytical outputs are audit-ready and traceable.

Fast & Flexible Turnaround

Optimized workflows and responsive project management for rapid execution without compromising data quality or regulatory compliance — timeline-driven delivery.

One-Stop CRO Platform

Comprehensive analytical and biopharma services across new biological entities and chemical drugs under one expert platform — eliminating multi-vendor complexity.

Trusted Scientific Partnership

Ethics-based collaborations grounded in transparency, integrity, and scientific accountability. We function as an extension of your internal analytical team.

Global Regulatory Alignment

Testing strategies designed for FDA, EMA, CDSCO, and WHO submissions. Data packages structured for direct CTD inclusion — no rework at submission stage.

PhD-Led Expert Team

Four PhD-level scientific leaders with combined 100+ years of pharma, biotech, and regulatory experience — hands-on involvement in every project from design to report.

Quality & Compliance

Regulatory-Ready at Every Stage

Our quality system ensures every analytical output meets the documentation, traceability, and data integrity standards demanded by global regulatory agencies.

ISO 9001:2015

Quality Management System certification

WHO GMP

World Health Organization Good Manufacturing Practice

US FDA

21 CFR Part 11 data integrity & submission standards

EMA / ICH

European Medicines Agency & ICH guideline alignment

GLP

Good Laboratory Practice — OECD Principles

CDSCO

Central Drugs Standard Control Organisation India

All methods validated per ICH Q2(R1) with complete audit-ready documentation
21 CFR Part 11 compliant electronic data management and traceability
Standard Operating Procedures (SOPs) for every analytical workflow
Qualified instrumentation with documented calibration and maintenance records
Out-of-specification (OOS) and out-of-trend (OOT) investigation protocols
Data packages structured for direct CTD Module 3 inclusion
Regular internal audits and management reviews aligned with ISO 9001:2015
Reference standard management and reagent qualification programs

Our Quality Commitment

Our Approach

How We Work With You

A three-step, ethics-driven partnership model designed to deliver reliable analytical outcomes that advance your regulatory goals.

Understand Scientific Needs

We start with a deep discovery of your project requirements, compound characteristics, regulatory pathway, and timeline — designing the optimal analytical strategy from day one.

Build Trusted Partnership

Transparent, ethics-driven collaboration with clear milestones, open communication, and scientific accountability — functioning as an integrated extension of your team.

Deliver Quality Outcomes

Regulatory-ready analytical data packages with consistent global quality — delivered on time, audit-ready, and structured for direct submission without rework.

Management Expertise

PhD-Led Scientific Leadership

Our founding team brings 100+ combined years of experience across pharma, biopharma, analytical sciences, and regulatory affairs — ensuring scientific rigor on every project.