Regulatory Affairs

1. Biotech, Pharmaceuticals and Advanced Therapies

We provide robust, integrated services for biotech, pharmaceutical, and advanced therapy (ATMP) companies, supporting the transition of therapeutic innovations safely and efficiently from concept through clinical trials to global market clearance.

Our services include:

• Regulatory Strategy & Roadmaps
  Global path-to-market planning, gap analysis, and classification assessment.
• Agency Engagement & Meetings
  End-to-end management, briefing books, and direct representation for FDA, EMA, and national competent authorities (FDA INTERACT, Pre-IND, End-of-Phase 2 (EOP2), and Type C/D meetings, EMA Scientific Advice, other).
• Submissions & eCTD Publishing
  Authoring, publishing, and dossier lifecycle management for INDs, IMPDs/CTAs, and MOH filings.
• Marketing Applications
  Full preparation, compilation, and submission of NDAs, BLAs, and MAAs.
• Expedited Pathways & Designations
  Strategic filing for high-unmet-need programs including ODD, RMAT, Breakthrough Therapy, Fast Track, and PRIME.
• Lifecycle & Post-Approval Support
  Protocol amendments, DSURs, long-term follow-up (LTFU), and ongoing regulatory compliance.

2. Medical devices & IVD

Navigating global regulatory requirements for medical devices and IVDs requires a strategy tailored to the technology, target markets, and applicable regulations. GSAP helps companies define the right regulatory pathway, manage global submissions, and successfully bring products to market while providing ongoing regulatory guidance throughout the product lifecycle.

Our services include:

Strategy

• Regulatory strategy development, assessment, and optimization
• Medical device classification and submission strategy

Regulatory ongoing support

• Design and development support from a regulatory perspective
• Risk Management Consulting
• Standard review and assessment
• Remediations of DHF / device file

Submissions

• EU Technical File or Design Dossier Compilation to obtain CE Marking Approval (for all classes I-III)
• FDA Pre-Investigational Device Exemption (Pre-IDE) consulting
• Participate in meetings with the FDA
• FDA 510(k) submissions for obtaining FDA certification
• FDA De Novo submission support for Medical Device companies
• US Premarket Approval (PMA) consulting services
• Preparation and submission of regulatory applications for ROW i.e. Israel, Canada (list of countries available upon request)

Clinical Writing

• Preparation of clinical evaluation plan and report (CEP & CER) for Medical Devices
• Preparation of performance evaluation plan and report (PEP & PER) for IVDR
• PMS
• PSUR
• SSCP
• Clinical literature review
• Scientific Writing
• White papers

Post Market

• Investigation and reporting of incidents and adverse events
• Support on corrections and removals
• FDA Form 483 and Warning Letter Analysis, response and recovery
• Medical Device registration
• Obtaining Certificate of Free Sale
• Deciding on when to submit product changes and Writing Letters to the File
• Regulatory review of Labelling and User Manuals
• Annual updating of the Clinical Evaluation Plan & Report / Performance evaluation Plan & Report