DEVELOPMENT SERVICES

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)
     

  • Osmolality
     

  • Optical/ Specific Rotation
     

  • Total Organic Carbon (TOC) – For water and cleaning validation testing
     

  • Other typical compendial testing and wet chemistry

 

PRE-CLINICAL

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"
     

  • Formulation Optimization
     

  • Analytical Development 
     

  • Spray Method Development
     

  • Process Development 
     

  • Stability Studies
     

  • Animal Toxicology Material

 

STABILITY SERVICES

Renaissance offers a full range of stability services to support your development and commercial product including:

  • ICH Conditions

  • Custom Conditions

  • 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.

REGULATORY SERVICES

 

Our Regulatory Group is here to support your product's compliance needs including:
 

•Audit Oversight

•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 

VALIDATION SERVICES

 

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.

SITE TRANSFER

 

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.

If you’d like to contact Renaissance for more information on our Contract Development and Manufacturing Services,