Our Services
Regulatory and Development Strategy
Identify gaps in scientific data (CMC, non-clinical, clinical).
Develop actionable regulatory strategies for your product.
Recommend opportunities for expedited approvals.
Tailor development plans to align with business objectives.
Provide guidance on risk mitigation and regulatory compliance.
Regulatory
Submission Services
Support human and animal small and large molecule products (generics, prescription, and over-the-counter), combination products and device submissions.
Prepare and submit DMFs, INDs, INADs, NDAs, NADAs, BLAs, ANDAs, ANADAs, 510Ks, PMAs, through Post Approval Supplements.
Support all types of FDA meetings through meeting package and request preparation, meeting strategy and facilitation, agency negotiation, and sponsor representation.
Ensure submissions meet FDA standards and expectations to streamline approvals.
Provide ongoing regulatory guidance throughout the approval process.
R&D
Project Management
Manage R&D projects from concept to regulatory submission.
Oversee technical transfers for drug substance or product manufacturing.
Supervise analytical testing and CMC-related changes.
Coordinate cross-functional teams to ensure timelines are met.
Provide progress tracking and risk management for submissions.
Due Diligence
Assess product portfolios for acquisition or licensing opportunities.
Evaluate regulatory compliance and potential risks.
Review scientific and technical data for informed decision-making.
Provide executive-level due diligence reports.
Offer strategic recommendations for portfolio optimization.
Other
FDA-Related Services
Serve as your US agent for FDA communications.
Review scientific and regulatory documents for accuracy.
Conduct corporate and individual FDA training sessions.
Advise on compliance best practices.
Provide ad hoc regulatory guidance as needed.