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About
Business
- Domestic
- International
R&D
Manufacturing
Careers
Contact
Global
- India
- Indonesia
- USA
- UK
- South Africa
- Kazakhstan
- Spain
- Ukraine
- MENA
- Germany
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Welcome to Macloeds Pharma Medical

You can use this site to report an adverse event or product quality complaint. You can also ask a medical information inquiry.

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What Can We Help You With? *Report an Adverse Event:
Adverse events are sometimes known as side effects and are unwanted or unexpected events or reactions to a medicine or device.Request Medical Information:Report a product quality Issue:

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Data Privacy:

All personal information reported in relation to a complaint or a side effect will be processed in accordance with applicable data protection legislation. Your report is used solely for the scientific evaluation of the medicine and product quality. Side effects are filed in our global safety database and the data is regularly analysed for overall patterns. Macleods may share reported complaints and side effects with health authorities as mandated by law. However, no personally identifiable details will be shared. Macleods will retain the data as long as required by law.

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Key divisions

Clinical
Bioanalytical
Pharmacokinetic and statistical
Quality Assurance
Data Protection

Clinical

Spread across 27,400 sq. ft, in Mumbai and Ahmedabad.
Supported by a NABL accredited clinical lab that has advanced machines such as Dimension EXL 200 (biochemistry), Sysmex XN 550 (haematology) and a LIS system to record, manage and store lab data.
Subject registrations carried out, using biometrics
Subject screening carried out to ensure stringent compliances (staging, height/ weight and volunteer registration, doctors’ room, ECG and X-ray).
Dosing and phlebotomy area available.

Pharmacy with controlled condition storage available.
Comprises of clinical pharmacological unit (CPU), with 248 beds.
Sample separation and storage room available, with a capacity for 48,000+ samples.
Round-the-clock monitoring is carried out by qualified doctors.
Contains a fully-equipped ICU.

Bioanalytical

Spread across 7700 sq. ft.
Facilitates method development and validation from human matrices (blood, serum, plasma and urine).
Has carried out 400+ validated methods.
Equipped for investigative procedures for low detection, chiral assays, light sensitivity, unstable molecules and conjugated and unconjugated assays.
Studies on invitro equilibrium phosphate and bile salts binding carried out.

Facilitates invitro release test (IVRT) and invitro permeation test (IVPT) on cadaver skin.
Comprises of a laboratory outfitted with 20 LC/MS/MS highly sensitive equipment.
Facility for controlled sample storage with a capacity for 32,000+ samples available.
Equipped with 21 CFR-compliant software (Analyst/ Chromleon/ Diffusion Master)

Pharmacokinetic and statistical

This is a SAS-powered statistical analysis software unit.
Enables two/ three/ four-way crossover BE studies as well as replicate crossover studies.
Facilitates parallel BE studies and steady-state BE studies.
Facilitates Invitro studies.
Facilitates Skin blanching studies.

Quality Assurance

Strictly adheres to GCP, GLP and regulatory requirements through online and retrospective audits.
Carries out in-house system and facility audits and outsourced services.
Has SOPs to ensure the uniformity of procedures, across the clinical, analytical and statistical sections.

Data Protection

Controlled access available, to ensure data confidentiality and integrity.
Dedicated servers available for software and laboratory data.
Separate archiving area for the documentation resulting from the QA procedures available.