Licensing - Macleods

Out-licensing

Our out-licensing expertise ranges across regions such as Australia, New Zealand, the Middle East, South America and a few countries in Europe. Backed by strong product development and regulatory team, we are always ready to support our partners in the varied and dynamic regulatory scenarios across different markets. With a strong emphasis on cGMP practices and having experience of audits from various agencies like European agencies and others, we have established a strategic partnership across Europe, Australia and other geographies. We are committed to building long-lasting, mutually beneficial relationships with all our partners.

In-licensing

To leverage our on-ground global marketing presence, we actively seek to increase our product portfolio and evaluate our in-licensing opportunities that can in turn complement our existing line of products. We are open to suggestions from our partners, with a vision of a long-term partnership.

An eye for uncompromising quality

INDIA

USA

ETHIOPIA

EUROPE

IVORY COAST

MALAYSIA

ZIMBABWE

SOUTH AFRICA

UGANDA

SAUDI ARABIA

SOUTH AFRICA

UKRAINE

WHO GENEVA

KENYA

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.

Facilitating Global Partnerships for Quality Medicines

Out-licensing

In-licensing

An eye for uncompromising quality