Regulatory Affairs and CMC

PharmaLex offers the whole range of regulatory services required by pharmaceutical companies. Beside the strong technical, regulatory and scientific expertise of our teams, we pride ourselves particularly on our ability to successfully conduct large Regulatory Outsourcing Programs and Marketing Authorization Transfers following M&A activities as well as our international footprint (“Global Reach – Local Presence”).

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    Strong technical, regulatory and scientific expertise

    • Complete Procedure management and health agency contacts in all regions worldwide:
      • Handling of initial marketing authorization applications and line extensions worldwide
      • Full lifecycle management and maintenance service across all regions including but not limited to CMC and safety variations, renewals, de-registrations, CCDS roll-out, referral procedures, handling of post approval commitments and translation activities
    • Global roll-out strategy for new submissions including due diligence activities
    • CMC compliance and remediation projects
    • Consultancy and regulatory operations during M&A activities
    • Change control procedures / CMC writing for chemicals and biologicals
    • Electronic submission services in all formats worldwide
    • Providing regulatory intelligence with regard to new or revised legislation as part of our tactical support

    We offer global solutions covering the entire product lifecycle

     Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.

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    Regulatory Affairs and CMC Services

    PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).

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    With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.

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    CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.

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    Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.

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    Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.

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    PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.

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    Global Approach

    PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

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