Regulatory and Compliance Solutions
With the rapid technological advancements and swift development of healthcare products, the life sciences and healthcare landscape is evolving exponentially. Navigating the complex regulatory requirements to bring a product to market has become more challenging than ever.
SOMA's Compliance Solutions team offers the expertise needed to lead or support FDA filings. Our solutions focus on developing customized plans for submissions, facilitating pre-submission and post-submission interactions with regulatory authorities. Our regulatory experts possess specialized knowledge of various regulatory jurisdictions.
We provide strategic guidance at every stage of the product development process.
SOMA Compliance Solutions offers expert support in:
- Regulatory Assessment
- CMC Development and Manufacturing Strategies
- GMP Manufacturing
- Connections to CDMO/CMO/CRO and GMP Manufacturing Facilities
- Connections to Contract Testing Labs and Assay Development Labs
- Due Diligence
- Global Regulatory Strategy Development
- Agency Interaction: Representing clients during pre-IND meetings and other interactions, including preparation and development of pre-meeting packets.
- FDA Inspection Preparation
- FDA Advisory Panel Preparation and Meeting Support
- Acting as Designated Agent for Non-US Manufacturers
- Documentation: Preparing and submitting regulatory documents, including IB, IND, IDE, CTD summaries, CTD tables, CTA, NDA, BLA, and MMA.
- Pre-market Submissions: 510(k), PMA, BLA, HDE
- Technical Papers and Abstracts
- Writing and Developing Standard Operating Procedures (SOPs)
- Batch Production Records
- Review and Critical Appraisal of Technical and Scientific Reports
- Annual Progress Reports
- Literature Searches and Bibliographies
With SOMA’s Compliance Solutions, you can navigate the regulatory landscape more effectively and bring your products to market with confidence.
