The Pharmaceutical Experience and Reputation You Can Trust
DRUGS
Our drug counseling bunch has master ANDA Consultants, NDA Consultants, and IND Consultants to offer the best help for our customers. Vernix Ltd FDA Consultants has top to bottom information on the most proficient method to set up all FDA drug entries including:
- ANDA application (Abbreviated New Drug Application)
- NDA application 505 (b)(2) (New Drug Application)
- IND application (Investigational New Drug)
- DMF application (Drug Master File)
Dissimilar to other Pharmaceutical counseling firms, our confirmed administrative experts have all around joined experience building solid associations with FDA specialists. Allow our educated staff to give you full-administration for your accommodation or fill in as an accomplice to direct you through the medications FDA pathway. Most Pharmaceutical think-tanks will prompt you that the FDA requires pre-clinical and clinical information giving the wellbeing and adequacy of the medication. The FDA will ask about the assembling processes too. Every achievement in the process is huge and assuming there is inadequate planning, the medication advancement methodology will be defective. Our FDA drug specialists will guarantee toward the finish of every FDA meeting, the customer is clear with what is expected to push ahead. Alongside a very much evolved system for your medication, Vernix Ltd offers the accompanying administrations to our drug customers:
- FDA preparation bundle
- Pre-IND meeting
- FDA interchanges and gatherings for all stages
- Pre-NDA meeting
- Vagrant medication assignment
- Clinical preliminaries coordination
- Writing audits
- Logical examination
- 513(g) Request for Information
- ANDA reasonableness petitions
- Specialized archives audit
- FDA guidelines understanding
Regardless of whether it is an IND FDA application or an ANDA, numerous FDA entries are not supported at first. Vernix Ltd has the medication mastery you want to expand your odds of starting endorsement, saving you both time and assets.
The reinforcement of our prosperity has been our remarkable consumer loyalty and customer maintenance.
In an everchanging worldwide market, makers of drug items should confront the difficulties of a worldwide store network and worldwide clinical preliminaries, but worldwide endorsements and worldwide commercialization are fulfilling. The pathways for drug item advancement are progressively perplexing, requiring administrative necessities past those of the FDA.
Our gathering of administrative specialists has given vital counseling to pharma customers of all sizes from virtual new businesses to enormous drug organizations and can assist you from the beginning phases of your advancement with projecting to advertise endorsement. Vernix Ltd has long periods of involvement in FDA, EMA, COFEPRIS, Health Canada, and other administrative offices.
In any case, on the off chance that you really want direction through plan improvement, administrative methodology, technique advancement, and solidness program, Vernix Ltd can help.
Areas of BRG consulting expertise include:
• Help with vital intending to push the item ahead
• Scientific technique improvement and approval
• Process improvement
• Plan strength studies and time span of usability evaluation
• Detailing improvement and scale-up
• Survey strategy improvement and approval
• Gear capability (IQ/OQ/PQ)
– Survey CMC areas
– Guidance on specialized areas of INDs, NDAs, ANDAs, BLAs, 505(b)(2)s
– Survey IND/NDA yearly reports
– Survey Annual Product Reviews (APRs)
• Clinical Supplies Project Management: We can uphold your clinical supplies exercises and configuration bundling, draft naming, diagram a conveyance methodology, or direct activities either inside or at workers for hire.
• Quality Assurance (QA) and Quality Control (QC) Consulting: We can uphold your Quality unit – or even capacity as your Quality Assurance office.
• Reviews: Vernix Ltd’s group of examiners can help your merchant capability endeavors by directing project workers or provider GXP reviews for your benefit.
We can uphold your clinical supplies exercises and configuration bundling, draft naming, layout a conveyance procedure, or regulate activities either inside or at project workers.