Sterile Manufacturing Solutions
Global Regulatory Support Services: Navigating the regulatory environment can be complex. To assist you, BioPharma Solutions brings a comprehensive portfolio of regulatory support services as part of our sterile contract manufacturing solutions to help you with your regulatory filings, including:
New drug applications and...
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Integrating Science and Technology
Lyophilization Technology, Inc. (LTI) was formed in 1992 to provide an extensive range of scientific services and technical support in freezing and freeze drying. As a Contract Development and Manufacturing Organization (CDMO), our services range from product and process development through...
Your Hands-On Quality and Regulatory Specialists
Regulatory Consulting Services: Strategic and Tactical Compliance Consulting
• Regulatory Agency Issue Resolution (483’s, deficiency letters, …)
• Evaluation of Commitments (vendors, outsourcing)
• FDA Interface (Protocol review, deficiency response)
• Vendor Qualification
• GMP Expert Consultants (Consent Decrees)...
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Providing expert GXP auditing, training and consultancy services, IAG remediation and mock inspections performed by former MHRA inspectors. EPiC is a leading provider of expert GXP auditing, training, and consultancy services to the global pharmaceutical industry, including pharmaceutical...
AVS is a global, full-service minority-owned company focused on quality management, regulatory compliance, and engineering services. Our mission is to provide innovative solutions to the pharmaceutical, biotech, medical device, and diagnostic industries from concept to care. AVS is committed to...
PharmaKnowl is a Saudi-based regulatory consulting firm, licensed by SFDA, helping global pharmaceutical, biotech, and MedTech companies succeed in the Saudi market. We specialize in regulatory, clinical, pharmacovigilance, and quality services, fully aligned with SFDA & GCC regulations, and...
A results-oriented boutique consulting firm specializing in biopharmaceutical, pharmaceutical, cell, medical device, food, medical cannabis, and natural health products & therapeutics. We are highly skilled in quality & manufacturing operations management, product & process development,...
Charles River supports customers’ efforts to discover new therapies for improved human health, beginning with the earliest use of research models in discovery and continuing across the development pipeline through proof of concept. From our commitment to ensuring continuous global availability of...
Clinigen are a global regulatory service provider that supports clients through the clinical and post-marketing phases of the medicine lifecycle. Our ability to hold marketing authorisations and our deep hands-on experience working across both the unlicensed and licensed phases means we stand apart...
Pharmaceutical Consulting Services in Validation. Valoit Inc. provides FDA and SOX regulatory compliance services, catering primarily to entities within the pharmaceutical, biotech, medical device, and diagnostics industries. With a robust portfolio that spans audit assessments, validation, and...
