adminBiologics/Biosimilars
hartered Pharma Consultants offers comprehensive biologics compliance consultancy services tailored to meet the regulatory requirements of the US, EU, Health Canada, and MHRA. Chartered Pharma Consultants team of experts ensures that your biologics products, including cell and gene therapies, monoclonal antibodies, and biosimilars, comply with the stringent standards set by various regulatory bodies.
US (FDA)
- Biologics/Biosimilars License Application (BLA) (Biologics 351a & Biosimilars 351k): Required for the approval of biologics, including detailed information on the manufacturing process, facilities, and product testing.
- Current Good Manufacturing Practice (cGMP 21 CFR Part 600): Regulations enforced by the FDA to ensure the quality and safety of biologics.
- Investigational New Drug (IND) Application: Necessary for clinical trials, including preclinical data, protocols, and investigator information.
EU (EMA)
- Marketing Authorization Application (MAA): Required for the approval of biologics, including comprehensive data on quality, safety, and efficacy.
- Good Manufacturing Practice (EU GMP Annex 2): Standards enforced by the EMA to ensure the consistent production and control of biologics.
- Clinical Trial Application (CTA): Required for conducting clinical trials, including detailed protocols and safety data.
Health Canada
- New Drug Submission (NDS): Required for the approval of biologics, including detailed information on the product, manufacturing, and clinical data.
- Good Manufacturing Practices (GMP): Regulations to ensure the quality and safety of biologics.
- Clinical Trial Application (CTA): Necessary for conducting clinical trials, including preclinical and clinical data.
MHRA (UK)
- Marketing Authorization (MA): Required for the approval of biologics, including detailed information on quality, safety, and efficacy.
- Good Manufacturing Practice (GMP): Standards enforced by the MHRA to ensure the consistent production and control of biologics.
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Clinical Trial Authorization (CTA): Required for conducting clinical trials, including detailed protocols and safety data.
Chartered Pharma Consultants can help navigate these complex regulatory landscapes, ensuring your biologics products meet all necessary compliance requirements.
Contact us to discuss your needs and discover how you can benefit from the extensive expertise of Chartered Pharma Consultants.
Email : info@charteredpharmaconsultants.com
Phone: +353 1 564 3967