Biologics

Biologics represent a significant frontier in biopharmaceuticals, encompassing a diverse range of products derived from biological sources, including living organisms and their components. These complex products—ranging from vaccines and cell therapies to gene therapies and recombinant proteins—offer innovative solutions for both common and rare diseases. Due to their intricate nature and sensitivity to environmental factors, biologics require specialized handling and rigorous compliance with regulatory standards.

At SOMA, we provide comprehensive support across the entire biologics development lifecycle, ensuring that your products meet regulatory requirements while maintaining the highest quality standards. Our services encompass:

1. Compliance, Regulatory Strategy, and FDA Submission

• Regulatory Strategy Guidance: We evaluate and guide all aspects of your regulatory strategy for biologics development, advising on optimal pathways for approval.
• Due Diligence Assessments: Our team performs meticulous evaluations to ensure your product's compliance with FDA regulations.
• Application Support: We assist in the preparation and submission of IND, NDA, BLA, and other applications, including Orphan Drug Designation and Fast Track requests.
• FDA Interactions: We represent clients in FDA meetings and communications, providing ‘FDA style’ reviews of submissions to enhance approval prospects.

2. CMC Development

• Regulatory and Quality Assurance: Our services include quality-based manufacturing, analytical method development, and validation.
• Formulation and Stability: We assess formulation development and evaluate stability data, ensuring compliance with regulatory CMC submissions.
• Risk-Based Strategies: We design risk-based strategies to manage product development effectively, overseeing contract services as needed.

3. Nonclinical Development

• Strategic Nonclinical Planning: We provide strategic support for nonclinical studies, including GLP consulting and safety assessments tailored for biologics.
• Regulatory Compliance: Our team reviews study protocols and reports to ensure scientific merit and adherence to regulatory standards.

4. Clinical Development

• Clinical Strategy and Support: We conduct clinical gap analyses and develop product manufacturing plans, offering regulatory expertise for all stages of clinical development.
• Protocol Development: Our services include crafting clinical protocols for Phases 1-4 and providing oversight for clinical trials, including CRO selection and management.

5. Audits and Compliance Checks

• Facility Compliance Audits: We conduct GMP, GLP, and GCP compliance audits, ensuring your operations meet industry standards.
• Data Integrity Audits: Our audits assess data integrity and validation, including computer systems validation and compliance with 21 CFR Part 11.

Navigating the complexities of biologics development requires a partner with deep industry knowledge and regulatory expertise. At SOMA, we are dedicated to supporting your journey from concept to market, helping you bring innovative biologics to patients efficiently and compliantly. Contact us to learn how we can assist you in achieving your goals in the dynamic field of biologics.