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PRODUCT DEVELOPMENT & REGULATORY STRATEGIES

Our tightly integrated regulatory, technical, operational and business experience drives product development and regulatory strategies of exceptional efficiency, clarity, speed and robustness. Because we can appreciate complex interactions, we anticipate and avoid development and regulatory pitfalls. Whether it is early stage long range planning or late stage go to market planning, Seraphim will lead you to on‑time and on‑budget goal achievement.

REGULATORY SUBMISSIONS & MEETINGS

We have complete experience in successfully planning, drafting, editing and defending the full range of technical and regulatory documents and meetings including:

Pre-IND, INDs/IDEs/CTXs, BLAs/NDAs/MAs, 510(k)s/PMAs, IVDD/MDD Dossiers

Pre-IND, IND, Advisory Committee Meetings

DMFs, Orphan Designations & Export Application

APHIS/CDC Import, LR/SAT & Specialty Applications

Product Labeling, Marketing & Sales Materials and Scientific Publications

Adverse Events, Complaint & Compliance Actions

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PRE-CLINICAL & CLINICAL TESTING

Developing robust, time and cost-effective protocols is a Seraphim specialty. We use advanced planning, vendor selection and implementation methods to minimize the risk of study failure or compliance problems. Our Outsourcing Services group can quickly source and efficiently manage the CRO/CMO services needed for any program.

OPERATIONS, QA & QC SUPPORT

We can help you dramatically improve manufacturing, analytics, and QA/QC operations. We bring years of experience in those disciplines at both management and line level responsibility. We can help with a wide range of tasks including:

Method, SOP and Policy Development

Production Process Assessment & Improvement

Outsource Planning & Implementation

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COMPLIANCE AUDITS

Developing robust, time and cost-effective protocols is a Seraphim specialty. We use advanced planning, vendor selection and implementation methods to minimize the risk of study failure or compliance problems. Our Outsourcing Services group can quickly source and efficiently manage the CRO/CMO services needed for any program.

TRAINING

Seraphim’s standard and customized training programs focus on your needs. Our training programs provide your staff with the knowledge and skills needed for program success. Our training curriculum spans technical, regulatory and other disciplines. We can couple in-house training with ongoing consulting to quickly address immediate needs, with real feedback and follow-up, while eliminating travel and time off-site.

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CRISIS INTERVENTION & RESOLUTION

When crisis blooms, whether a crash deadline, project emergency or FDA compliance event, we jump into action calmly and objectively. Our experts know how to solve problems quickly and effectively, with consent decrees, FDA submission rejections and objections, and 483s/warning letters. We can show you how to achieve rapid closure to the toughest problems before they escalate to disasters.

ON-SITE PROFESSIONAL STAFFING

We understand finding the right people for critical positions can be challenging. Our experts can work on-site to immediately fill your staffing needs, including manufacturing, regulatory, clinical, project management personnel for short- or long-term assignments. We can help you find, assess and train new hires so you can build the right team.

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