Services

Research & Development

Formulation Development

Preformulation
Formulation Optimization using QbD
Lab Scale Process Optimization
Clinical Study Sample manufacturing
Stability Studies
Feasibility Testing (POC)
Contract Development/Co-Development
Out Licensing of Developed Products
Complete NCE, Generic, and OTC Product Development
Repurposing Phase I or II Dosage Form Clinical Setbacks via Turnkey Formulation Solutions
510(k) Medical Devices Development

Analytical Development

Analytical Method Development using AQbD
Deformulation and Reverse Engineering
Advanced Characterization Studies (SEM-EDAX, Elemental Mapping, Confocal Microscopy, Rheology)
In Vitro Permeation Testing (IVPT) using Human Cadaver and Animal Skin Models
In Vitro Release Testing (IVRT) and Dissolution
Heat Effect Skin Flux Studies
Residual Drug Content Analysis of Clinical Study Samples
In Vitro Adhesion Testing (Peel, Tack, Shear, Release Force)
Physical Testing (Air Permeability, Tensile, Elongation, Folding Endurance, etc.)
Mechanical Tensile Testing (Applicators, Pen Injectors, Vaginal Rings, Device Performance Testing, Dose Uniformity for Drug Devices, etc.)

Technical Consulting

We provide exceptional technical guidance for the Product development of Transdermal patches, Oral films, Topical creams, ointments, gels, lotions, solutions, Drug-Device combination products and related Complex drug products.

Formulation Development Support
Process Development and Scale-up Assistance
Analytical Development and Validation Guidance
In vitro testing guidance and deficiency response
Manufacturing Process Optimization using QbD and CFR-Compliant Statistical Software
Lab Setup – R&D
Pharmaceutical Manufacturing Facility Setup (Greenfield and Brownfield)
CMC Regulatory, Technical, and Documents Review
Due Diligence Services
Compliance Audits
API DMF Critical Review
Evaluation of Innovative Platforms and Technologies
Expertise in Developing Non-Infringing Novel Patentable Formulations
Addressing FDA Deficiencies with scientific justifications
Packaging Development and Drug-Device Combination Requirements
Clinical Study Strategizing and Monitoring (Clinical Endpoint, PK, Adhesion, Irritation, and Sensitization)

Training and development

**Monitoring of In-vitro studies**

We are involved in actively overseeing the initiation, progress and conduct of in-vitro experiments at CROs for Clients:

In vitro Release testing (IVRT)
In vitro Permeation testing (IVPT) using human cadaver, human epidermis, mucosal membranes, porcine skin, etc.
In use stress/heat flux studies
In vitro nail permeation studies
In vitro feeding tube studies
Drug release studies or dissolution testing
Extractable and leachable studies (Sample incubation as per in use conditions)
Adhesion testing (Peel, Tack, Shear, Release force, etc.)
Condom compatibility studies
Performance testing of Applicators, Pen-injectors, Vaginal Rings, Drug Devices, etc.
Advanced Characterization Studies (SEM-EDAX, Elemental Mapping, Confocal Microscopy, Rheology)

Toxicological Evaluations

Toxicological Assessments
Impurity Qualification
In-Silico Assessments

Packaging Development

Selection of Packaging Components
Qualification and Characterization
Package Testing as per USP and ASTM
Extractable Studies
Compilation of Design History Files for Drug-Device Combination Products

Research & Development

​

Formulation Development

Preformulation

Formulation Optimization using QbD

Lab Scale Process Optimization

Clinical Study Sample manufacturing

Stability Studies

Feasibility Testing (POC)

Contract Development/Co-Development

Out Licensing of Developed Products

Complete NCE, Generic, and OTC Product Development

Repurposing Phase I or II Dosage Form Clinical Setbacks via Turnkey Formulation Solutions

510(k) Medical Devices Development

Analytical Development

Analytical Method Development using AQbD

Deformulation and Reverse Engineering

Advanced Characterization Studies (SEM-EDAX, Elemental Mapping, Confocal Microscopy, Rheology)

In Vitro Permeation Testing (IVPT) using Human Cadaver and Animal Skin Models

In Vitro Release Testing (IVRT) and Dissolution

Heat Effect Skin Flux Studies

Residual Drug Content Analysis of Clinical Study Samples

In Vitro Adhesion Testing (Peel, Tack, Shear, Release Force)

Physical Testing (Air Permeability, Tensile, Elongation, Folding Endurance, etc.)

Mechanical Tensile Testing (Applicators, Pen Injectors, Vaginal Rings, Device Performance Testing, Dose Uniformity for Drug Devices, etc.)

Technical Consulting

We provide exceptional technical guidance for the Product development of Transdermal patches, Oral films, Topical creams, ointments, gels, lotions, solutions, Drug-Device combination products and related Complex drug products.

Formulation Development Support

Process Development and Scale-up Assistance

Analytical Development and Validation Guidance

In vitro testing guidance and deficiency response

Manufacturing Process Optimization using QbD and CFR-Compliant Statistical Software

Lab Setup – R&D

Pharmaceutical Manufacturing Facility Setup (Greenfield and Brownfield)

CMC Regulatory, Technical, and Documents Review

Due Diligence Services

Compliance Audits

API DMF Critical Review

Evaluation of Innovative Platforms and Technologies

Expertise in Developing Non-Infringing Novel Patentable Formulations

Addressing FDA Deficiencies with scientific justifications

Packaging Development and Drug-Device Combination Requirements

Clinical Study Strategizing and Monitoring (Clinical Endpoint, PK, Adhesion, Irritation, and Sensitization)

Training and development

Monitoring of In-vitro studies

We are involved in actively overseeing the initiation, progress and conduct of in-vitro experiments at CROs for Clients:

In vitro Release testing (IVRT)

In vitro Permeation testing (IVPT) using human cadaver, human epidermis, mucosal membranes, porcine skin, etc.

In use stress/heat flux studies

In vitro nail permeation studies

In vitro feeding tube studies

Drug release studies or dissolution testing

Extractable and leachable studies (Sample incubation as per in use conditions)

Adhesion testing (Peel, Tack, Shear, Release force, etc.)

Condom compatibility studies

Performance testing of Applicators, Pen-injectors, Vaginal Rings, Drug Devices, etc.

Advanced Characterization Studies (SEM-EDAX, Elemental Mapping, Confocal Microscopy, Rheology)

Toxicological Evaluations

Toxicological Assessments

Impurity Qualification

In-Silico Assessments

Packaging Development

Selection of Packaging Components

Qualification and Characterization

Package Testing as per USP and ASTM

Extractable Studies

Compilation of Design History Files for Drug-Device Combination Products

**Monitoring of In-vitro studies**