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Product Development
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Clinical Trials
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Quality
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GxP Audits
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Regulatory Affairs
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Pre-authorisation
- Regulatory Roadmap
- Scientific Advice
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Product information
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Dossier preparation
- Dossier Gap Analysis
- MA Handling
- Post-authorisation
- Regulatory outsourcing
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Pre-authorisation
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Pharmacovigilance
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QP Service / Importer
Quality services
Unlock the potential of your pharmaceutical development with SciencePharma’s expert consulting quality services. We provide comprehensive support in all aspects of CMC (Chemistry, Manufacturing, and Controls) development involving pharmaceutical development (medicinal product studies design), Nitrosamines risk analysis, setting proper limits for organic and inorganic impurities, assessment of genotoxicity potential, stability study design and Quality dossier preparation to meet stringent regulatory standards. Our team ensures meticulous attention to details and can ensure your products meet the highest standards of safety and efficacy.
Our widely experienced experts gladly advise on analytical method transfer for chemical, biological and biotechnological products, manufacturing process validation (taking into account EMA Guideline) and technology transfer. Whether you’re transitioning between laboratories or scaling up production, our consultants provide strategic guidance to streamline the transfer process and maintain product consistency and quality.
Moreover, our QP (Qualified Person) services, including drug product certification, provide an added layer of assurance and expertise. With our unique combination of consulting and engineering services, we deliver seamless GMP integration, setting us apart as leaders in the pharmaceutical consultancy sphere.
Elevate your pharmaceutical endeavors with SciencePharma quality services today and experience the difference unparalleled expertise and commitment to quality can make.