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Pharmaceutical Regulatory Affairs Support
Helping our Clients Design and Implementation Innovative
and
Global Regulatory Strategies
Our team provides expert support in the design and implementation of innovative and global regulatory strategies to expedite product development and registration of drugs, biologics and combination products for all stages of development (preclinical to post-marketing approval).
Regulatory support.
Navigating the changing regulatory landscape is an ongoing challenge for many involved in the development, approval, and manufacture of pharmaceutical drug products.
- Dedicated regulatory resources to protect
your confidentiality with global expertise
and support. - Proactive approach to early engagement
with regulators. - Flexible options that provide customised
submission support.
Our Regulatory Support Services span the following phases of your products development pathway:
Clinical Trials
- Writing or review of Investigator Brochure and IMPDs including CMC, non-clinical and clinical sections, clinical protocols.
- INDs/CTAs and amendmentspreparation & submission
- DSURs, Annual Safety reports preparation & submission
Regulatory Strategy, Gap Analysis & Classifications
- Drugs, Biologics, OTC Products, Combination Products
- Development plans, Gantt charts
- Gap analysis for “reborn” projects and / or during due diligence
Regulatory Agency Interactions Support
- Scientific Advice, Pre-IND, EOP2 meetings, pre-NDA/BLA meetings, Protocol assistance
- Orphan Drug Status designation EU & US
- ATMP classification
- PRIME designation, Fast track designation, breakthrough therapy designation
Marketing Applications
- MAA / NDA / ANDA / BLA
