Focus Expertise & Approach of our

Drug Development Service

Integral BioSystems offers high quality, specialized drug development services in pre-clinical stage pharmaceutical R & D. With a focus on ophthalmic solutions and a wide array of dosage forms, our team specializes in guiding projects from early-stage research to final technology transfer. From method development to consulting on strategic approaches, we are dedicated to delivering tailored solutions that drive success. 

Company Focus and Expertise

Expertise in Drug Development

  • Expertise with ophthalmic eyedrops and injections, infusions, injectable, intranasal, dermal, rectal, ungual, otic, sublingual, polymeric sustained release
  • Early-stage R&D to final technology transfer
  • R&D Method Development
  • cGLP Method Development
  • Toxicology Supplies for cGLP studies
  • cGLP Stability Studies
  • cGLP Dose Verification
  • cGLP End-Use Studies

Consulting on Strategy

  • Ophthalmic Drug Delivery
  • Sustained Release

Drug Delivery Routes

  • Ophthalmic, Otic, Dermal, Rectal, Intranasal, Ungual, Sublingual, Otic, Injectables (SQ, IM, IV, Intravitreal)

Molecules

  • Small molecules
  • Proteins 
  • Peptides
  • Nucleic Acids (Oligos, DNA, RNA)

Dose Forms

  • Liquid injections
  • Dispersions
  • Emulsions
  • Nano-and micro-suspensions
  • Hydrogel depots
  • Sublingual films
  • Lipid Nanoparticles (proprietary)
  • Creams and ointments

Phase-Specific

  • Phase I-II-III (NCE, 505b2)
  • Generic

Development Phase

  • Early-stage R&D formulation development
  • Scale up
  • Process Engineering
  • Technology transfer
EYE
SKIN_311526257
intranasal drug delivery

Approach to Drug Development

We offer a systematic, step-wise development plan.

The Factors of a Successful Project Plan

The success of a project is dependent on the following factors: 

  1. “The Big Picture” —Strategic Project Planning, Risk/Benefit Analysis of Strategies
  2. “The Tactical Details” —Detailed Project Lay-out, with all essential linked activities
 

Failure in either one of the two basic categories can result in loss of time and money for the company. While 50,000 feet strategy development is done as part of the company’s goals development objectives, Integral BioSystems can offer key input into the risk/benefit analyses of each strategic approach to assist the development team. This could range from the budgetary requirements, as well as regulatory considerations to get the drug from the laboratory to its validation in the clinic. The second category flows naturally from the first. Integral BioSystems develops a detailed plan to take the concept from the laboratory to the clinic. Once the strategy is in place, the tactical plan is of critical importance, since it results from the critical analysis of the place in the overall project plan of each detail, resulting in an absolute minimum of time wasted. 

Project Planning Steps 

In order to develop the detailed project plan and the proposal, Integral BioSystems will meet with your development team to discuss the scope of the project and its objectives.  This occurs after both companies have signed a Confidential Disclosure Agreement (CDA).  At this point, data is evaluated, then challenges and proposed clinical indication and route of administration of the drug are discussed. In this regard, we can offer expert consulting on the process, or a full-blown tactical plan of the program. The plan thus prepared is then evaluated for cost. 

Program Synopsis

Our drug development program consists of: 

  1. Review of Existing Data and formation of strategy
  2. API Characterization
  3. Analytical Method Transfer and Stress Degradation Studies
  4. Pre-formulation
  5. Prototype Building
  6. Drug Product Method Development
  7. Specifications Documents
    • Raw materials
    • Drug Product
  8. R&D Stability (3 months)
  9. Scale-Up/ Process Engineering
  10. cGLP Method Validation Protocol and Data Generation
  11. Batch Record Development for Toxicology Batches
  12. Toxicology Batch Prep and Release to Specification
  13. cGLP Dose Verification Protocol and Data Generation
  14. cGLP ICH Stability
  15. Tech Transfer to cGMP Facility
Every program is custom-built!
Project team

Learn more about our drug development services:


Ready to embark on a journey of pharmaceutical innovation with a trusted partner? Contact Integral BioSystems today to explore how our systematic approach to drug development can propel your project forward. Let’s collaborate to turn your vision into reality!