Renaissance offers a full analytical lab to support your development and finished product testing needs. Our capabilities include:
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 – For creams, ointments, gels, nasal sprays, and injectables
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)
Optical/ Specific Rotation
Total Organic Carbon (TOC) – For water and cleaning validation testing
Other typical compendial testing and wet chemistry
We offer the resources to develop your concept into a product that is ready to go to the clinic. We offer the following services:
Pre-formulation & Formulation Development"
Spray Method Development
Animal Toxicology Material
Renaissance offers a full range of stability services to support your development and commercial product including:
DEA Product Stability
CLINICAL TRIAL MATERIAL
Renaissance has the flexibility to offer clinical trial material in varying scale to support small to large requirements.
We have dedicated cGMP clinical fillers for micro-dose and multi-dose nasal products as well as assembly machines for these drug-device combinations as well.
We have just installed an integrated filler and assembly machine to support unit-dose nasal for larger clinical requirements which could also support a commercial launch up to a million units per year.
Our Regulatory Group is here to support your product's compliance needs including:
•Regulatory Inspections (FDA, EMA, MHRA, ANVISA, etc.)
•Client cGMP Audits
•Coordinates and provides responses to any observations issued by Regulatory or Clients
•Conducts Internal Systems Audits
•Conducts External Audits
•Supports Regulatory filings with clients
•Provides CMC review prior to submissions
•Author CMC sections for client submissions
•Electronically publish modules 1-5 of all client submissions
•Conducts Internal PAI Readiness Inspections and gap analysis
•Conducts Regulatory Guidance Reviews
Our Validation Team can design and complete IQ/OQ/PQ on equipment, facilities, utilities, and environments.
We offer process and packaging validation, aseptic process simulations, filter validations, cleaning /sterilization development and validation.
Renaissance has the technical know-how and the installed capacity to support the site transfer of your approved drug product in a nasal format or in a small volume parenteral.