Expertise in FDA (21 CFR 58, 210/211, 820, 11, 312, 314, 812, 803, 600, 203, 205) compliance.

EU regulatory support, including EU MDR, IVDR, EudraLex Volume 4, and MDSAP (Canada, Australia, Brazil, Japan, U.S.).

Compliance with ISO standards, including ISO 13485:2016, ISO 9001:2015, ISO 14971:2019 (risk management), ISO 14155 (clinical investigations), ISO 14644 (cleanroom standards), ISO 11137/11135 (sterilization), ISO 17665, ISO 17025 (testing labs), ISO 14001 (environmental management).

ICH Guidelines Compliance:

• Good Clinical Practice & Safety: ICH E6(R2), E6(R3), E3 (Clinical Study Reports), E8 (General Considerations for Clinical Trials), E9 (Statistical Principles for Clinical Trials), E17 (Multiregional Clinical Trials).

• Good Manufacturing Practice & Pharmaceutical Quality: ICH Q7 (GMP for APIs), Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System), Q11 (Development & Manufacture of Drug Substances).

• Nonclinical & Safety Regulations: ICH M3 (Nonclinical Safety Studies), S6 (Biopharmaceuticals Safety Evaluation).

• Compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP).

• International regulatory compliance, including Health Canada, WHO GMP, UK MHRA, Japan PMDA, NMPA (China), REACH (EU), California Prop 65.

Support for FDA regulatory submissions: IND, NDA, ANDA, IDE, 510(k), PMA, De Novo, Biologics License Applications (BLA), Drug Master Files (DMF), Breakthrough Therapy Designations (BTD).