R & D Laboratory Services

Metis Consulting Services helps pharmaceutical and biotech companies navigate the complexities of drug development and achieve regulatory approval for small molecules and biologics.

Do not let regulatory complexities or laboratory hurdles hinder your pharmaceutical development journey. Contact Metis Consulting Services today to unlock your product’s full potential and achieve regulatory success. Our offerings include Small Molecule Development Services, Biologics Development Services, and Cross-Functional Expertise.

Our services are tailored for pharmaceutical and biotech companies involved in the development of small-molecule drugs, including, but not limited to, antivirals, antibiotics, CAR-T cell therapeutics, and other anti-cancer drugs.

Small Molecule Development Services:

• Formulation Development: Expertise in designing formulations for oral, topical, and parenteral delivery, ensuring stability and bioavailability.
• Analytical Method Development: Specialized techniques for quantifying and characterizing small molecules, ensuring quality and compliance.
• Regulatory Support: Navigating complex regulatory pathways, including FDA submissions and compliance with international standards.
• Scale-up and Manufacturing: Transitioning from lab- to production while maintaining product quality and efficiency.

Biologics Development Services:

• Process Development: Designing and optimizing manufacturing processes, including purification and formulation.
• Analytical Characterization: Ensuring purity and potency with advanced techniques for analyzing biologics, such as ELISA and chromatography. Regulatory Strategy: Developing comprehensive regulatory strategies for biologics, including BLA submissions and compliance with ICH guidelines.

Cross-Functional Expertise:

• Project Management: Our comprehensive approach involves coordinating multidisciplinary teams to streamline development timelines and meet project milestones.

• Quality Assurance: Metis’ unwavering support for implementing robust quality systems compliance with cGMP standards and regulatory requirements.
• Technology Transfer: Facilitating seamless transfer of processes and knowledge between development, manufacturing, and quality control.
• Supply Chain Management: Optimizing supply chain logistics to ensure timely delivery of materials and minimize risks of product shortages.
• Lifecycle Management: Supporting post-approval activities, including process optimization, variation filings, and life cycle extension strategies.

Confidence and Security:

Our complete menu of laboratory services and experienced consultants give our biotech pharmaceutical manufacturer clients the security to meet and exceed regulatory requirements and best practices confidently.