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”).

Contact our specialists to tailor a service plan

    Add a header to begin generating the table of contents

    Strong technical, regulatory and scientific expertise

    Services spanning the product lifecycle for pharmaceuticals, biologics, and medical devices


    Our comprehensive regulatory service portfolio supports companies from development to initial submission through launch and lifecycle management for new products as well as established product portfolio maintenance. We combine deep market expertise with operational and technical capabilities to help companies navigate the complexities of global and local regulations efficiently while supporting risk mitigation, accelerating time-to-market and expanding market reach.

    Key areas of expertise

    • Global clinical/regulatory strategy development Regulatory submissions and procedures Chemistry, manufacturing, and controls (CMC)
    • Product information and labelling
    • Regulatory informatics and regulatory operations services
    • Lifecycle maintenance at global and local affiliate level
    • Clinical trial applications (IND/CTA)
    • eCTD services

    Gain deeper insights into the Clinical Trial Directive (CTR) and Clinical Trial Information System (CTIS) 

    Read our latest blog series to learn what the CTR means for your trials, what you need to do to transition, including registering for CTIS and generating a harmonized dossier, and how the new transparency rules will affect you.   

    Reg Blog

    Available Resources

    Regulatory Affairs and CMC Services

    PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the FDA, 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).

    More Info

    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.

    More Info

    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.

    More Info

    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.

    More Info

    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.

    More Info

    Pharmalex is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. We will advise on and review activities and processes for healthcare compliance that fall […]

    More Info

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

    More Info

    Contact Us

    Contact Form

    Complete this form to stay in contact with us.

    Global Approach

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

    Scroll to Top