Research & Development Services

Our team of experts can provide a turnkey solution to fulfill all of your development needs.

Renaissance offers premier development services supported by highly experienced, in-house scientists and engineers

RESEARCH & DEVELOPMENT SERVICES

With our recently expanded R&D Laboratory and expansive supporting services, Renaissance is positioned to meet your project deadlines and support all of your development objectives. Whether you represent a small virtual group, global enterprise, or something in between, Renaissance will provide your program with world class service and support.

Renaissance’s development services include:

  • Pre-formulation & Formulation development
  • Analytical development and validation
  • Spray Characterization method development and validation
  • Process development and validation
  • Clinical Trial Material Manufacturing
  • QbD Services
  • Lab scale / Clinical trial material / Scale-up support
  • On-site stability programs (ICH and custom)
  • Validation and regulatory support
  • Formulation & Analytical Development

    Renaissance employs a dedicated development team to support a wide range clients’ development and finished product testing needs.

    • Pre-formulation & formulation development
    • Formulation optimization
    • Analytical development, validation, and testing
    • Spray method development
    • Device selection (for nasal & inhalation devices)
    • Process development
    • Stability studies (CRT, intermediate, accelerated, and ICH Zone conditions as needed)
    • Animal toxicology material
  • R&D / GMP Testing Support

    Renaissance R&D and Analytical facilities offer full lab services to support your program’s development and finished product testing needs. Below are a few of our capabilities:
    • Gas chromatography (GC) – Equipped with Flame Ionization Detector (FID), Thermal conductivity detector (TCD), and Headspace
    • High-Pressure Liquid Chromatography (HPLC) – Equipped with Photodiode Array (PDA), Ultraviolet visible (UV/VIS), Refractive Index (RI), and Fluorescence (FLR) detectors
    • Dissolution Apparatus – Apparatus 1 (Basket), Apparatus 2 (Paddle), Apparatus 3 (Reciprocating Cylinder)
    • Viscosity testing/measurement
    • Particle size analysis – Microscopic method and Light Obscuration method (USP <788>; USP <789)
    • Moisture analysis by Karl Fischer titration – For drug product and drug substance
    • Ultraviolet Visible Spectrophotometry (UV/VIS) – For qualitative and quantitative analysis
    • Fourier Transform Infrared Spectroscopy (FTIR) – For ID testing of drug substance, drug product, and components (USP <197K>, <197F>, <197S>, ATR)
    • Osmolality
    • Optical/ Specific Rotation
    • Total Organic Carbon (TOC) – For water and cleaning validation testing
    • Other typical compendial testing and wet chemistry

     

  • Clinical Trial Materials

    From development to early clinical trials, we have equipment to support even the smallest batches. Below is a list of our clinical filling capabilities:
    • Dedicated cGMP clinical fillers for unit-dose, bi-dose, and multi-dose nasal products
    • Complementary assembly machines for these drug-device combinations
    • Recently installed integrated filler and assembly machine capable of supporting higher demand nasal products
    • cGMP injectable line set-up to support clinical demand
    • Contact our sales team to discuss your clinical trial requirements

     

  • Regulatory Services

    Renaissance has a robust history of global regulatory compliance and offers support to our customers in the following areas:
    • Audit Oversight
    • Regulatory Inspections (FDA, EMA, MHRA, ANVISA, etc.)
    • Client cGMP Audits
    • Coordinate and provide responses to any observations issued by any Regulatory Agency or client teams
    • Conduct internal systems audits
    • Conduct external audits
    • Support Regulatory filings to client’s needs
    • Author CMC sections for client submissions
    • Provide CMC review prior to submissions
    • Electronically publish modules 1-5 of all client submissions
    • Conduct internal PAI Readiness inspections and gap analysis
    • Conduct Regulatory Guidance Reviews

     

  • Development Services

    Renaissance prides itself on its experienced team and complete on-site facilities enabling turnkey solutions, no matter the stage of your program. Supplemental support services can include:
    • On-site stability storage and service for development and commercial applications
    • Standard ICH conditions
    • Customizable stability chambers to meet your unique products requirements
    • DEA product stability
    • On-site validation services
    • Process and packaging validations
    • Aseptic process simulations
    • Filter validations
    • Cleaning/sterilization development and validation
    • Equipment/facility/utility validation (in-house IQ/OQ/PQ capabilities)
    • Experienced project and account management teams
    • Project management provided from kick-off
    • Commercial account management provided upon launch

     

  • Site Transfer

    Whether you are looking to kick-off a new product, build on from an established development program, or initiate a site-transfer, Renaissance has the team in place to ensure your product’s advancement.
    • Available capacity to support commercial production of intranasal and sterile injectable products
    • Depending on the stage of your product, experienced project or commercial account managers are assigned to meet project deadlines and ensure smooth transition to the facility.
    • Robust product review ensures alignment and congruency with our in-house capabilities.

     

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