Product Portfolio | Pharmaffiliates

Formulation
Development

USFDA-Inspected Analytical Testing Facility

USFDA-Inspected
Analytical
Testing Facility

cGMP Complaint Formulation Development Facility

cGMP Complaint
Formulation Development
Facility

Product Development Report & Dossiers

Product Development
Report & Dossiers

Forced Degradation Excipient Compatibility Studies

Forced Degradation
Excipient Compatibility
Studies

Research & Development (Formulation) Services
  • Research &
    Development
    (Formulation)
    Services
Fully Equipped Research Facility
  • Fully Equipped
    Research Facility
Skilled Technical Manpower
  • Skilled Technical
    Manpower
Serving Domestic & International Markets
  • Serving Domestic
    & International
    Markets
Mission Commitment to innovation, quality & Regulatory Compliance
  • Mission:
    Commitment to
    innovation, quality
    & Regulatory
    Compliance
Focus on Generics, NMEs, OTCs & Veterinary Nutraceuticals, Herbal Formulations
  • Focus on Generics,
    NMEs, OTCs &
    Veterinary
    Nutraceuticals,
    Herbal Formulations

Our Strength

  • Process Management

    Process Management

    1. Change Control
    2. Over 200 SOPs – From receipt to reporting & archival
    3. Records & Data Management
    4. Equipment IQ/OQ/PQ and traceability maintained
    5. Robust data integrity controls
  • Compliance

    Compliance

    1. FDA audited (Last inspection: Jul, 2024)
    2. 21 CFR Part 11 and GAMP5 validated systems
    3. Training, Deviations & investigations
    4. OOX management & CAPA
    5. Proven track record with FDA, EMA, and global regulatory bodies
    6. Risk management
    7. ISO 17034, ISO 17025, ISO 9001
  • Analytics & Continuous Improvement

    Analytics & Continuous Improvement

    1. Trends
    2. Quality metrics
    3. Management review meetings
    4. Operational metrics
    5. Fast turnaround with responsive technical support
    6. High client satisfaction and repeat business rate
  • Quality Assurance

    Quality Assurance

    1. 100% QA review of data in GMP
    2. Fully cGMP-compliant, aligned with ICH guidelines
    3. Vendor evaluations
    4. USP/IP quality standards
    5. Robust data integrity controls
    6. Internal audits
    7. Scientific leadership: Postgraduates, SMEs with Vast Experience

Service Portfolio

Pre-formulation
Services

Formulation
Research &
Development

Analytical
Services &
Development

Technology
Transfer

Product
Improvement &
Reformulation

Project
Management
Excellence

Impurity Profiling

Dedicated team and facility for separation and purification of difficult compounds
(Enantiomers, Close eluting compounds and many more)

  • Impurity Profiling

  • Impurity Profiling

    Identification

  • Impurity Profiling

    Isolation

  • Impurity Profiling

    Purification

  • Impurity Profiling

    Characterization
    & SER

  • Impurity Profiling

    Synthesis

Dosage Form

Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation
  • Analytical Method Creation & Validation

Work Process

Project Initiation

Project Initiation

Analytical Method Creation & Validation

Analytical Method Creation & Validation

Reformulation Research

Reformulation Research

Reformulation Optimization

Reformulation Optimization

Reformulation Development

Reformulation Development

Project Management Across Stages

Project Management Across Stages

Scale-up & Technology Transfer

Scale-up & Technology Transfer

Project Initiation

Project Initiation

Analytical Method Creation & Validation

Analytical Method Creation & Validation

Reformulation Research

Reformulation Research

Reformulation Optimization

Reformulation Optimization

Reformulation Development

Reformulation Development

Project Management Across Stages

Project Management Across Stages

Scale-up & Technology Transfer

Scale-up & Technology Transfer

Each project begins with Project Initiation and Scoping, ensuring a clear understanding of client objectives and regulatory requirements. This is followed by in-depth Reformulation Research and Development, where innovative methods are explored to enhance efficacy, stability, and performance.

Our Analytical Method Creation and Validation guarantees precision and reliability throughout every stage of formulation. We emphasize Reformulation and Optimization to achieve superior product outcomes, backed by robust data and scientific insight. Finally, through Scale-up and Technology Transfer, we ensure smooth transition from lab to production, while our Project Management Across Stages provides seamless coordination and quality assurance at every milestone.

Key Instruments Analytical / Formulation

Key Instruments Analytical Key Instruments Analytical Mobile1 Key Instruments Analytical Mobile2

ICP-OES - Make/model - Perkin Elmer Optima 8000

ICP-MS - Make/model - Agilent 7800

HPLC - Make/model - Waters Alliance e2695, Waters 2489 (Arc) with UV/Vis and PDA detectors and RI detector

UPLC - Make/model - Waters Acquity UPLC H class

GC - with FID, TCD, ECD and NPD — Make/model - Perkin Elmer Clarus 580 and Agilent 7980A with HS 7694E

Stability Chambers - Newtronic

LCMS - Waters Acquity SQD2

CATEGORY
CHROMATOGRAPHY
SPECTROSCOPY
WET CHEMISTRY
DISSOLUTION
TECHNIQUES / INSTRUMENTS
HPLC, UPLC, GC
UV-Vis, FTIR, ICP-MS, ICP-OES, LCMS
pH, Conductivity, Titrations
Dissolution & Disintegration Testing (USP <711>/<2040>)
CATEGORY TECHNIQUES / INSTRUMENTS
CHROMATOGRAPHY HPLC, UPLC, GC
SPECTROSCOPY UV-Vis, FTIR, ICP-MS, ICP-OES, LCMS
WET CHEMISTRY pH, Conductivity, Titrations
DISSOLUTION Dissolution & Disintegration Testing (USP (711)/(2040))

Key Instruments Analytical / Formulation

  • Mini Rapid Mixer Granulator GMP Model

    Mini Rapid Mixer
    Granulator GMP Model

  • Duo Press – Bilayer Tablet Press

    Duo Press – Bilayer
    Tablet Press

  • Sieve Shaker

    Sieve Shaker

  • Octagonal Blende

    Octagonal Blende

  • Fluid Bed Dryer

    Fluid Bed Dryer

  • Homogenizer

    Homogenizer

  • Ointment Filling

    Ointment Filling

  • FB Tech CI (Lab Model) - Fluid Bed Processor

    FB Tech CI (Lab Model) - Fluid Bed Processor

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