Our mission is to ensure the generation of accurate and precise findings.

Contact Us sohail.chohan@silextacmc.com
Our Services

What We Provide

Pharmaceutical Consulting

Starting with the definition of the Target Product Profile (TPP) and continuing through the preclinical and nonclinical stage, clinical development, licence submission, and maintenance, we can help you develop effective regulatory and quality strategies to bring your product to market on time and within budget.

Biopharmaceuticals Consulting

Silexta Bio specialises in delivering expert technical CMC and regulatory CMC guidance for the development of biopharmaceutical products, ensuring excellence in drug substance and drug product manufacturing. Our services encompass strategic management and operational support throughout the entire product development lifecycle, from early-stage IND/IMPD activities to final MAA/BLA filings.

Advanced Therapies

Silexta Bio possesses a wealth of experience in the advanced therapies arena, providing targeted technical and CMC support, notably in the fields of CAR-T cells and AAV gene therapy.

Who We Serve

With an average of 30 years of expertise, our team of bioprocess industry veterans provides a wide range of support & services, assisting our clients at every stage of the product development & commercialization lifecycle.

Multinational Biopharmaceutical Companies
Early-Stage Biotechnology Companies
Cell & Gene Therapy Companies
CDMOs, CMOs, Laboratories & Suppliers
Investment Firms & Service Providers

About Us

    CMC Product Development Support
  • Be your steadfast partner throughout every phase of product development, providing consistent and comprehensive technical, quality, regulatory, and project management support, ensuring a successful process execution.
  • Provide technical CMC input into upstream and downstream unit operations
  • Optimize your product development timeline and ensure a smooth path to success by relying on our expertise in preparing or evaluating CMC development plans and strategies. We diligently assess technical and regulatory gaps, providing you with actionable insights to meet crucial CMC milestones.
  • Identify, qualify, and manage contract manufacturers (CMOs) and other service providers for outsourced programs
  • Offer CMC program and project management
  • Develop and oversee technical transfers, process validation, process characterisation and comparability strategies
  • Reviewing technical documents and input into CMC sections of regulatory dossiers (INDs/IMPD, BLA/MAA and post-approval submissions)
    • Quality & Regulatory
  • Establish Quality Systems and Quality Manual
  • Support and develop the Target Product Profile (TPP) and other key quality attributes
  • Develop CMC regulatory strategies and risk profiles
  • Write Module 3 and support meetings with regulatory authorities (FDA, EMA, etc.) relating to CMC
  • Conduct CGXP compliance audits.
  • Review of IND and BLA applications and amendments
  • Offer PAI readiness, responses to FDA 483
  • Provide responses to CMC questions from health authorities
    • Manufacturing Strategy & Operations
  • Leverage the expertise of our CMC professionals to ensure the production of high-quality drug material and the generation of comprehensive data that supports global regulatory filings at every phase of your product's lifecycle.
  • Develop a short and long term supply chain strategy
  • Assist CMO choice, clinical, and commercial supply agreement negotiations
  • Oversee CMO operations and compliance matters
  • Improve delivery time to clinics and customers

Contact Us

Email Us :sohail.chohan@silextacmc.com