Pharmaceuticals

In an era where advancements in pharmaceuticals have the potential to transform global health, delivering high-quality products efficiently is paramount. At SOMA Pharma Solutions, we are committed to accelerating the drug development process, ensuring that innovative therapies reach the market swiftly and safely.

Navigating the complexities of drug development can be challenging due to increasing competition, stringent regulatory requirements, and evolving technologies. Our team of seasoned professionals brings extensive expertise in:

• Drug Discovery & Development: From initial concepts to clinical applications, we provide support throughout the entire development lifecycle.
• API & Formulation Development: We specialize in various dosage forms, employing cutting-edge techniques, including taste masking and clinical trial manufacturing.
• Commercial Manufacturing: Our facilities adhere to cGMP standards, ensuring products are FDA-inspected and approved.

We understand that each drug development project is unique. That’s why SOMA offers customized consulting and strategic planning to address your specific challenges. Our services include:

• Regulatory Strategy and FDA Submission:
  • Expert guidance on regulatory pathways and options.
  • Preparation of IND, NDA, BLA, and other submissions, complete with ‘FDA style’ reviews.
  • Representation in FDA meetings and advisory discussions.
• CMC Development:
  • Quality assurance and compliance services tailored to your needs.
  • Analytical method development and validation processes.
  • Risk-based strategies for effective product management.
• Nonclinical Development:
  • Strategic planning for nonclinical studies and FDA submission support.
  • GLP consulting and safety assessments to ensure compliance and scientific merit.
• Clinical Development:
  • Comprehensive gap analyses and clinical regulatory expertise.
  • Support for clinical trials, including protocol development for all phases.
  • Coordination with CROs for streamlined operations and oversight.
• Audits and Compliance:
  • GMP, GLP, and GCP compliance audits to ensure operational integrity.
  • Pre-Approval Inspection readiness and data audits to maintain quality standards.

At SOMA Pharma Solutions, our mission is to empower pharmaceutical companies to navigate the drug development landscape effectively. By leveraging innovative approaches and regulatory expertise, we help you deliver impactful solutions that enhance public health and improve patient outcomes.

Let us guide you through every step of the drug development process, from nonclinical testing to commercialization, ensuring you achieve your goals and bring quality therapies to market.

Contact us today to learn how SOMA Pharma Solutions can support your journey to successful drug development.