COVID-19

Dear Partners,

Necessitated by the unprecedented situation created by Covid-19, several industry events and tradeshows across the world have been postponed or stand cancelled. While we were looking forward to meet you, we at Piramal Pharma Solutions have had to take several precautionary measures to protect both our employees and customers, worldwide.

As we move forward in these extraordinary times, we want to assure you that that we are operational by taking the right safety measures and abundant precautions to ensure that we continue to support you and your patients.

While all of us are working remotely for now, you can schedule a discussion with us and we would be glad to help ensure you meet your pharmaceutical development and supply needs and thereby, your clinical and commercial timelines.

Please feel free to reach out to us at:
Stuart.Needleman@piramal.com

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

PiramalPharma Solutions Logo

Development Analytical Support Services

We offer analytical support services for oral solids, liquids, creams, ointments and sterile injectable from our facilities in the US, UK, and India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct drug development work in parallel,accelerating time to market and reduce costs for our customers.

API Properties

  • Chemical: Solubility (equilibrium/kinetic), hygroscopicity, thermal behaviour, log P, and stability.
  • Physical: Microscopy, particle size

Pre-formulation

  • Solubility
  • Forced degradation
  • Particle size
  • Excipient Compatibility
  • Fast content uniformity

Formulation

  • Analytical methods development/validation/transfer
  • Clinical supply release
  • ICH stability studies
  • Identification of unknown impurities
  • Cleaning validations

    ORAL SOLIDS STERILE INJECTABLES
    Comparator testing: Fixed dose combination, modified release formulations Extractable and leachable studies
    Blend uniformity Forced degradation studies
    Hardness / Friability / Bulk density Moisture content
    Disintegration Residual solvent determination
    Moisture (KF and LOD) Cleaning validation
    Particle size distribution (granules) Raw material, in-process, and finished product testing
    Sieve fraction analysis Dissolution testing (immediate and extended release)
  • Stability Studies
    • We currently offer stability programs with chambers covering -20°C, 2 ̶ 8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data needed for your filing.
  • Analysis of Support Formulation Development
    • Excipient Compatibility
    • Fast content uniformity
    • Bio-relevant Dissolution for formulation selection
    • Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients

Analytical (Microbiology)

  • Environment Monitoring of classified areas
  • Microbiological analysis of Water
  • Microbial enumeration test
  • Stability Studies along with preservative efficacy testing
  • All testing as GLP requirements.

Analytical Testing Services

  • Liquid chromatography (HPLC)
  • Diode array detectors (DAD)
  • Refractive index detector (RID)
  • Gas chromatography (GC)
  • Protein concentration (TOC)
  • UV/Vis
  • Infrared spectroscopy
  • Karl Fisher (KF) moisture analysis
  • pH determination
  • Total organic carbon (TOC)
  • Viscosity
  • USP particulate testing: HIAC 9705
  • Specific gravity
  • Dissolution testing
  • Particle size testing
  • Zeta potential