CMO/CDMO Services

CDMO Services:Squadron Pharmaceuticals offers comprehensive Contract Development and Manufacturing Organization (CDMO) services, guiding you from research and development to full-scale production of compliant formulations. We provide flexible solutions tailored to both small-scale and large-scale production needs, supporting every stage of drug development and commercialization.

• Dosage Forms: Expertise in a variety of forms, including tablets, capsules, and liquids.
• Customization: We tailor formulations to meet specific therapeutic and market requirements.
• Stability Studies: We conduct thorough stability studies to ensure product shelf life.

CMO Services:Our state-of-the-art R&D infrastructure enables us to provide international standard Contract Manufacturing services across various dosage forms and packaging options. Our diverse portfolio includes life-saving medications such as tablets, capsules, and liquid formulations. We utilize advanced manufacturing facilities to produce high-quality drugs that meet the rigorous demands of the pharmaceutical industry.

• Technology Transfer: We facilitate long-term supply agreements through effective technology transfer.
• Registration Batches: We produce batches specifically for regulatory submission and approval.
• Commercial Manufacturing: Our capabilities include high-volume manufacturing to meet commercial demands.

API, Excipients & Intermediates Supply

Squadron Pharmaceuticals specializes in sourcing and supplying high-quality Active Pharmaceutical Ingredients (APIs), excipients, and intermediates. Our commitment to quality and compliance ensures that we meet the stringent requirements of the pharmaceutical industry while supporting our clients’ diverse needs.

APIs: We offer a comprehensive range of high-purity APIs, ensuring full Drug Master File (DMF) support for regulatory submissions. Our APIs are sourced from trusted manufacturers and undergo rigorous quality control to guarantee their efficacy and safety.

• Quality Assurance: All APIs are manufactured in compliance with international standards, including WHO GMP and USFDA regulations.
• Custom Synthesis: We provide tailored synthesis solutions to meet specific client requirements.
• Regulatory Support: Our team assists clients with necessary documentation and regulatory submissions.

Excipients: Our portfolio includes a wide variety of pharmaceutical-grade excipients essential for formulating effective and stable drug products.

• Functional Properties: We offer excipients that enhance formulation performance, including binders, fillers, and stabilizers.
• Customization: Tailored excipient solutions to meet specific formulation needs.
• Technical Support: Our experts provide formulation development assistance to optimize excipient use.

Intermediates: We also specialize in supplying intermediates used in the synthesis of APIs, produced under strict quality controls.

• Sourcing: We leverage our global network to source high-quality intermediates that comply with regulatory standards.
• Manufacturing Capabilities: Our facilities can handle various scales of production, from small batches to large-scale manufacturing.
• Collaboration: We work closely with clients to develop and optimize intermediate products for their specific applications.

USFDA, EU-GMP, PIC’s

squadron pharma associated with business partners-USFDA, EU-GMP, PICs, GCC, Iraq, ANVISA, WHO, Russia, China and other regulatory approved sites…

Audit Readiness & Site Support

Squadron Pharmaceuticals offers comprehensive audit readiness and site support services to help pharmaceutical companies maintain compliance and prepare confidently for regulatory inspections. Our experienced team guides you through every stage of the audit process to ensure smooth and successful outcomes.

• Mock Audits: We conduct practice audits that simulate real regulatory inspections to identify gaps and improve preparedness.
• QP Audits: Qualified Person (QP) led audits ensure compliance with Good Manufacturing Practices (GMP).
• Technical Documentation Review: We examine quality systems, batch records, and validation documents to ensure completeness and accuracy.
• Corrective Action Support: We assist in developing and implementing corrective and preventive actions (CAPA) based on audit findings.
• Training & Consultancy: We provide tailored training sessions and expert consultancy to strengthen your audit readiness.

Regulatory Affairs & Compliance Support

At Squadron Pharmaceuticals, our dynamic Regulatory Affairs (RA) team is equipped to develop regulatory strategies and manage compliance, risks, and dossier submissions globally. We provide expert regulatory support to ensure adherence to international standards and assist in navigating the approval process. Our team collaborates closely with regulatory bodies to ensure that all products comply with local and international regulations.

RA Team Offers:

• Product/dossier development in CTD format
• Dossier compilation and due diligence
• EU CTD dossier filing through National, DCP, and MRP procedures
• Packaging design and development that meets regulatory and market demands

Services Provided:

• FDA Compliance: Adhering to U.S. FDA requirements for drug development and manufacturing.
• EMA Compliance: Meeting European Medicines Agency regulations.
• Global Market Compliance: Expertise in navigating regulatory authorities in regions such as South America, Africa, and Asia.

Product Developments & Validation

From R&D scale-up to commercial production, we offer flexible contract manufacturing solutions tailored to your timelines and specifications…