Our pharmaceutical consulting group has expert ANDA Consultants, NDA Consultants and IND Consultants to provide the best support for our clients. Biotech Research Group’s FDA Consultants has in-depth knowledge on how to prepare all FDA drug submissions 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)
Unlike other Pharmaceutical consulting firms, our certified regulatory professionals have well over 50 years of combined experience building strong relationships with FDA agents. Let our knowledgeable staff provide you with full-service for your submission or serve as a partner to guide you through the drugs FDA pathway. Most Pharmaceutical research companies will advise you that the FDA requires pre-clinical and clinical data providing the safety and efficacy of the drug. The FDA will inquire about the manufacturing processes as well. Each milestone in the process is significant and if there is insufficient preparation, the drug development strategy will be flawed. Our FDA drug consultants will ensure at the end of each FDA meeting, the client is clear with what is needed to move forward. Along with a well-developed strategy for your drug, Biotech Research Group offers the following services to our pharmaceutical clients:
- FDA briefing package
- Pre-IND meeting
- FDA communications and meetings for all phases
- Pre-NDA meeting
- Orphan drug designation
- Clinical trials coordination
- Literature reviews
- Scientific research
- 513(g) Request for Information
- ANDA suitability petitions
- Technical documents review
- FDA regulations interpretation
Whether it is an IND FDA application or an ANDA, many FDA submissions are not approved initially. Biotech Research Group has the drug expertise you need to increase your chances of initial approval, saving you both time and resources.
The foundation of our success has been our outstanding customer satisfaction and client retention.
In an everchanging global market, manufacturers of pharmaceutical products must face the challenges of a global supply chain and multi-national clinical trials, however international approvals and global commercialization are rewarding. The pathways for pharmaceutical product development are increasingly complex, requiring regulatory requirements beyond those of the FDA.
Our group of regulatory experts has provided strategic consulting to pharma clients of all sizes from virtual start-ups to large pharmaceutical companies and can help you from the early stages of your development project to market approval. Biotech Research Group has years of experience with FDA, EMA, COFEPRIS, Health Canada, and other regulatory agencies.
Regardless, if you need guidance through formulation development, regulatory strategy, method development, and stability program, BRG can help.
Areas of BRG consulting expertise include:
Pharmaceutical/biotech product development
• Assist with strategy planning to move product forward
• Analytical method development and validation
• Process improvement
• Design stability studies and shelf-life assessment
• Formulation development and scale-up
• Review method development and validation
• Equipment qualification (IQ/OQ/PQ)
• Advise on steps needed for robust, approvable filings including:
– Review CMC sections
– Advise on technical sections of INDs, NDAs, ANDAs, BLAs, 505(b)(2)s
– Review IND/NDA annual reports
– Review Annual Product Reviews (APRs)
• Clinical Supplies Project Management: We can support your clinical supplies activities and design packaging, draft labeling, outline a distribution strategy, or oversee operations either internally or at contractors.
• Quality Assurance (QA) and Quality Control (QC) Consulting: We can support your Quality unit – or even function as your Quality Assurance department.
• Audits: BRG’s team of auditors can assist your vendor qualification efforts by conducting contractor or supplier GXP audits on your behalf.
We can support your clinical supplies activities and design packaging, draft labeling, outline a distribution strategy, or oversee operations either internally or at contractors.