Drug Development Services for Innovative Solutions
Formulation Development Services for Complex Drug Products
Drug Development Consulting and Formulation Expertise
Integral BioSystems works with biotech and mid-size pharmaceutical companies to solve complex formulation challenges across a wide range of dosage forms and delivery routes. Our drug development consulting services begin with a strategic assessment of each molecule and its target indication, followed by a tailored formulation plan designed to de-risk the path to IND.
Our team brings deep expertise in ophthalmic drug delivery, including eyedrops, intravitreal injections, and sustained release inserts, as well as injectable, intranasal, dermal, rectal, sublingual, otic, and inhalation formulations. We also provide end-to-end R&D and cGLP analytical support, including method development, stability studies, dose verification, end-use testing, and toxicology supply preparation.
Whether your program requires early-stage preformulation studies, a new delivery strategy, or a full development plan from API characterization through technology transfer, our formulation development services are structured to move your molecule forward on schedule.
Drug Delivery Routes and Dose Forms
Integral BioSystems develops formulations across more than ten routes of drug administration, including ophthalmic, injectable (SQ, IM, IV, and intravitreal), intranasal, transdermal, rectal, sublingual, oral, otic, ungual, and inhalation. Each route requires a different formulation approach, and our team tailors excipient selection, release profile design, and stability strategies to meet the specific requirements of each delivery pathway.
We work across a broad range of dose forms, including liquid injections, dispersions, emulsions, nano- and micro-suspensions, hydrogel depots, sublingual films, lipid nanoparticles (proprietary), and creams and ointments. Our molecule experience spans small molecules, proteins, peptides, and nucleic acids (oligonucleotides, DNA, and RNA), across Phase I through Phase III programs, 505(b)(2) applications, and generic development.
Our Approach: From Strategy to Technology Transfer
Strategic Planning and Risk Assessment
Every successful drug development program depends on two factors: a sound strategic plan and a detailed tactical execution path. Integral BioSystems addresses both.
At the strategic level, our team conducts risk/benefit analyses of formulation approaches, evaluates budgetary and regulatory requirements, and helps your development team define the most efficient path from laboratory to clinic. At the tactical level, we translate that strategy into a detailed project plan with sequenced activities, clear milestones, and minimal wasted time. This systematic, step-wise approach ensures that every formulation decision supports your broader development objectives.
Project Planning Steps
Every engagement begins after both parties sign a Confidential Disclosure Agreement (CDA). From there, Integral BioSystems meets with your development team to evaluate existing data, discuss clinical indication and route of administration, and identify key formulation challenges. We then prepare either focused drug development consulting on specific decisions or a comprehensive tactical plan covering the full program scope. The resulting proposal includes a detailed project plan and cost evaluation.
The 15-Step Development Program
Our drug development services follow a 15-step program customized to each molecule and indication:
- Review of existing data and formation of strategy
- API characterization
- Analytical method transfer and stress degradation studies
- Pre-formulation
- Prototype building
- Drug product method development
- Specifications documents (raw materials and drug product)
- R&D stability (3 months)
- Scale-up and process engineering
- cGLP method validation protocol and data generation
- Batch record development for toxicology batches
- Toxicology batch prep and release to specification
- cGLP dose verification protocol and data generation
- cGLP ICH stability
- Tech transfer to cGMP facility
Every program is custom-built. Steps may be adjusted, expanded, or consolidated depending on the molecule, route of administration, and regulatory pathway. Our analytical development team supports each stage with method development and validation aligned to cGLP and cGMP requirements.
Analytical Development and cGLP Services
Formulation development and analytical development work hand in hand. Integral BioSystems provides method development, method validation, and stability-indicating assay design to support every stage of the drug development lifecycle, from early R&D through cGLP batch release and ICH stability programs.
Our analytical services include cGLP method validation protocols, dose verification, end-use studies, and stress degradation testing. We prepare complete data packages designed to support IND submissions and technology transfer to cGMP manufacturing partners.
Why Biopharma Teams Choose Integral BioSystems
Since 2009, Integral BioSystems has operated as a specialized drug development CRO from its Bedford, Massachusetts facility. Our team brings decades of combined experience across pharmaceutical formulation, analytical chemistry, and drug delivery science.
What sets our drug development services apart is the depth of our specialization. Over 80% of our client work involves ophthalmic programs, giving us one of the most concentrated portfolios of ocular formulation experience available in a CRO of our size. We also maintain active collaboration platforms in lipid nanoparticles, cyclodextrin-mediated solubilization, microencapsulation, and nano-/micro-crystallization.
Every program is led by senior scientists, with direct access to our formulation suites, ICH stability chambers, and analytical instrumentation. We work with biotech startups, mid-size pharma companies, and academic spinouts across the United States, Europe, and Asia-Pacific.
Frequently Asked Questions
What should a drug development CRO deliver for tech transfer?
A complete tech transfer package typically includes validated analytical methods, batch records, raw material and drug product specifications, stability data (R&D and cGLP ICH), process engineering documentation, and cGMP-ready manufacturing protocols. Integral BioSystems builds these deliverables into its 15-step development program.
What are preformulation studies?
Preformulation studies characterize the physical and chemical properties of a drug substance before formulation work begins. This includes solubility profiling, stability assessment, excipient compatibility, and API characterization, providing the data needed to inform formulation strategy and reduce downstream risk.
How does a drug development project begin at Integral BioSystems?
Every engagement starts with a Confidential Disclosure Agreement (CDA), followed by a scoping meeting to evaluate existing data, clinical indication, route of administration, and project challenges. The team then develops a strategic plan and detailed project proposal with cost evaluation.
Discuss Your Next Drug Development Project
Ready to move your molecule forward? Whether you need formulation development services for a specific dosage form, drug development consulting on your overall strategy, or a full program from preformulation through tech transfer, Integral BioSystems is here to help.