CMC Biologics
Our biopharmaceutical experts understand the importance of developing therapies for unmet needs, as well as the pressure of getting that drug from pipeline to market quicker. We also recognize that no two companies are the same, and therefore focus our efforts on providing flexible, tailor-made solutions to ensure every aspect of your drug development lifecycle is carefully planned and executed.
Contact our specialists to tailor a service plan
PharmaLex have an established and skilled multidisciplinary team of regulatory experts to support CMC, non-clinical and clinical areas.
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.
If you would like to register your interest in a training session or strategy workshops (remote or face-to-face), please contact us.
- Development and regulatory strategy considering regional requirements (e.g. US, EU, Canada, Japan, Emerging Markets)
- Gap Analysis / Due diligence
- Technical writing and compilation of regulatory documents
- Scientific advice and other health agency meetings
- Risk assessment
- Preparation of TPP
- Comparability exercises
- General ‘troubleshooting’, including investigations and root cause analysis and
support for CAPA - Deviation and change control preparation / review
- Method / process validation
- Process characterization
- Project management
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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Agency Interactions
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).
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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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Global Approach
PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.