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R & D ACTIVITIES
Facility
Our R & D Department occupies a 10,000 ft2 cGMP facility. This facility has a DEA license for schedule I - V products.
Development Team
Our talented team of R & D scientists are busy developing ANDAs and 505(b)2 NDAs. They have extensive experience with over 45 different active pharmaceuticals ingredients (API) and have developed patent-pending delivery systems.
Analytics
The analytical group is competent in the development and validation of analytical methods that meet the stringent requirements for filed products. They follow guidelines for USP/NF, EP compendial testing.
We have experience developing the
following dosage forms:
Oral Tablets
Oral Capsules
Oral Solutions and Suspension
Topical Solutions
Otic Preparations
following dosage forms:
Oral Tablets- OTC, Rx Only, and Narcotics
- Immediate-release
- Sustained-release
- Modified-release
- Sublingual
- Quick-dissolving
- Chewable
- Bilayer
- Coated
Oral Capsules- OTC, Rx Only, and Narcotics
- Powder-filled
Oral Solutions and Suspension- OTC, Rx Only, and Narcotics
- With or without sugars, dyes, or alcohols
Topical Solutions Otic Preparations
Key activities supported for an ANDA or 505(b)2 NDA
- Prepare development plan
- Evaluate API, excipients, and packaging materials
- Review and evaluate stability of API
- Verify analytical methods of API
- Conduct pre-formulation and formulation activities
- Request and attend pre-IND meeting with FDA (NDA only)
- Develop and validate test methods
- Perform cleaning verification studies
- Manufacture exhibit batch
- Conduct ICH stability studies
- Submit IND (NDA only)
- Coordinate BA/BE Biostudies
- Assemble application
- Submit ANDA or NDA in eCTD format
- Support pre-approval inspection
- Manufacture commercial batches
- Perform process validation testing