Companies With Products In Development: No longer virtual in structure and preparing for commercialization, challenges include limited manpower for regulatory submission and commercial readiness. There is often a need to balance investments among adding personnel, the costs of development and the expense associated with commercialization.
Our Development Services:
Preparing protocols, study reports, statistical plans, and NDAs/BLAs, 510(k)s, PMAs or other US or International regulatory submissions
Interacting with regulatory agencies
Reimbursement Strategies
Requesting, prepararing for and coordinating FDA meetings
Developing and implementing communication strategies
Developing pre-launch strategic plans, revenue forecasts & supporting market development efforts
Regulatory Support:
Regulatory writing and publishing INDs, NDAs, 510ks, or PMAs
Managing FDA interactions, including:
- Meeting requests
- Briefing documents
- Regulatory representation and filings
We can also help define your global regulatory strategies from pre-IND/CTA through NDA/BLA/MAA submission. Our team has successfully filed numerous INDs and over 60 NDAs, BLAs and MAAs.
Pre-clinical Support:
Designing, placing and monitoring safety/toxicology, & pharmacokinetics studies
Placing (obtain bids and assure adequacy of staff and of the program plan)
Audits and GLP monitoring of facilties for in vivo studies
Review and approval of final study reports
Close-out audits where needed
Clinical Support:
Preparing:
- Investigator brochures
- Protocols
- Informed consent documents
- Study reports
Organizing Medical Advisory Boards and DSMBs
Selecting and supervising CROs
Organizing and supporting Investigator Meetings
Training CROs and sites
Conducting GCP audits
Project Management:
- Programs
- Studies
- Budgets
- Timelines
We can also help define your comprehensive drug development plans, including formulation strategy.
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Malvern Consulting Group 490 Lapp Road,
Malvern, PA 19355
