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
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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
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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
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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
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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
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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
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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.