Regulatory services with robust foundations
- Strategic development of regulatory pathways for topical and other specialty drug products
- Proven expertise in pharmaceutical development including topical, rectal, otic and ophthalmic dosage forms
- Compilation and submission of high-quality regulatory dossiers to support product registration and approval
- Regulatory meetings and consultations with global health authorities
- Preparation of comprehensive development packages and regulatory correspondences with authorities
- Full management of pre-approval administrative processes to ensure smooth progression to market
Applications include:
- Pharmaceuticals, Biotech
- Academia, Universities, Institutes
- Veterinary products
- Cosmeceuticals, Dermaceuticals
- Complimentary medicines