OUR EXPERTISE & SERVICES
Expertise & Services
Development of Delivery System: design, documentation, IP (right to practice, Patents), equipment;
Drug Formulation Development: R&D, formulation, IP (right to practice, Patents), analytical and microbiological method developments, method validations, stability program;
Clinical Study Management: clinical batches, study design, study protocol, study monitoring;
Regulatory: pre-IND, IND, pre-NDA meeting data packages, eCTD NDA submission to achieve Market Approval;
Regulatory Affairs Consultants: Aside having knowledges of FDA regulatory/clinical requirements, we also have experiences with Health Canada, TGA, EU and MHRA requirements.
In addition, and most important, provide a pathway for “SPEED to Market” because of our cumulated experiences of over 60 years in this topical antimicrobial market.
Areas
Our Core Infection Prevention concentration focus on the following areas:
- Pre-Operative Site Preparations (with/without Applicator System);
- Patient Pre/Pre-Operative Skin Cleanser Preparations, i.e. body wash (with/without Dose Form Delivery System);
- Surgical Hand Wash/Rub, Professional/Patient Hand Wash/Rub Preparations (with/without Dispensing System;
- Prescription Oral Rinse Solution Preparations (with Dose Form Dispensing System);
- Nasal decolonization (with Dose Form Dispensing System).
Active pharmaceutical ingredient
Our drug product development will identify specific active ingredients aligned to your company/market needs:
- From contemporary Antimicrobial Molecules (I.e. CHG Active, with Alcohol and without (Aqueous);
- To “NEW” molecules Solutions;
- In addition, and specifically, we have entry to Exclusive (Lease or Ownership) Patented Dose Form Delivery Systems;
- And partnership with external GMP manufacturing and packaging sites.