Emerging biotech and specialty pharmaceutical companies face unique challenges in developing novel therapies.
These firms require CMC strategies tailored to breakthrough innovations, rapid regulatory approvals, and cost-effective manufacturing solutions.
Our specialized expertise supports small, virtual, and startup pharma companies by offering:

• Comprehensive early-stage CMC consulting to ensure a strong scientific and regulatory foundation.
• Lean yet scalable development strategies to optimize resources and streamline progress to first-in-human trials.
• Flexible collaboration models to support companies with limited in-house development infrastructure.
• Regulatory guidance for IND/IMPD filings to help navigate global submission requirements efficiently.

For mid-sized pharmaceutical companies, balancing scalability, regulatory compliance, and cost efficiency is key to success. We offer:

• Scalable formulation and process development ensuring seamless tech transfer from R&D to commercial manufacturing.
• Process optimization solutions that enhance efficiency while maintaining robust quality control.
• Regulatory documentation and lifecycle management to streamline market entry and post-approval compliance.
• CMC risk assessment and mitigation strategies to avoid costly delays in development and commercialization.

Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs) require expert analytical and scale-up support to deliver high-quality manufacturing solutions to their clients. Our support includes:

• Analytical method development and validation for in-process and release testing.
• Process scale-up and technology transfer support to ensure manufacturing consistency.
• Comprehensive quality control solutions to enhance compliance with global regulatory standards.
• Support for complex formulation manufacturing, including biologics, HPAPIs, and specialty injectables.

University-based incubators and research institutions play a critical role in early-stage drug discovery and development. However, transitioning academic research into industry-ready pharmaceutical products requires specialized CMC expertise. We assist in:

• Translating academic innovations into scalable drug development programs.
• Early-stage formulation and analytical support to guide proof-of-concept studies.
• CMC strategy development for grant-funded research projects to enhance commercialization potential.
• Regulatory roadmap guidance for academic spin-offs seeking funding and strategic partnerships.

Pharmaceutical equipment manufacturers are vital partners in the design and implementation of manufacturing processes. We provide strategic guidance that ensures their technologies align with regulatory expectations and client process needs. Our services include:

• Process design collaboration to ensure equipment capabilities support scalability, reproducibility, and process robustness.
• Validation strategy development, including performance qualification and integration into GMP manufacturing workflows.
• Support for equipment lifecycle documentation, including risk-based validation plans and compliance with FDA/EMA guidance.
• Technical documentation services to align with end-user regulatory submission requirements, facilitating smooth tech transfer.