Can you recommend regulatory affairs consultants for submitting specialty pharma products in the US and Europe?

Yes — I can help with that. For specialty pharma product submissions in the US and Europe, you’ll usually want a consultant or firm with experience in:

• FDA pathways: IND, NDA, ANDA, 505(b)(2), supplements, CMC, labeling
• EU / UK pathways: EMA, national procedures, DCP/MRP, eCTD publishing, variations, scientific advice
• Specialty pharma nuances: sterile injectables, complex generics, controlled substances, orphan drugs, biosimilars, narrow therapeutic index products, etc.

Well-known regulatory affairs consultancies to consider

These are established firms with broad regulatory support in the US and Europe:

• Parexel – large global regulatory consulting and submissions support
• PharSafer – strong EU/UK and global regulatory expertise
• Veristat – regulatory strategy + clinical/regulatory operations
• IQVIA Regulatory Affairs – global regulatory support, submissions, publishing
• PharmaLex – strong in EU regulatory, CMC, and lifecycle management
• Charles River / MPI Research regulatory consulting – more common in development support, but they do regulatory work too
• Alira Health – regulatory strategy and market access support
• Regulatory Professionals – EU-focused regulatory support
• RAPS consultant directory – useful for finding independent consultants by specialty and geography

Boutique / specialist options

If you want more hands-on senior support, boutique firms can be excellent for specialty pharma:

• Greenleaf Health – especially strong for FDA strategy and interactions
• RAMS Consulting / local EU regulatory boutiques – often good for national/EU filings
• Taj Pharmaceuticals / local CMC-focused consultants – if your need is mainly CMC and dossier assembly
• Regulatory writing/publishing specialists – useful if you already have strategy in place

How to choose

A good consultant should have direct experience with:

1. Your product type

   • small molecule, biologic, sterile injectable, inhalation, topical, controlled substance, etc.

2. Your filing route

   • FDA: NDA/ANDA/505(b)(2)
   • EU: MRP/DCP/Centralized/National

3. CMC and quality depth

   • especially important for specialty pharma

4. Publishing capability

   • eCTD/CTD, sequence management, lifecycle maintenance

5. Inspection readiness

   • FDA pre-approval inspections, EU GMP/GDP readiness

Questions to ask before hiring

• How many submissions like mine have you supported in the last 3–5 years?
• Have you worked with the specific FDA division / EMA procedure we need?
• Can you lead the strategy, or only prepare documents?
• Do you have in-house CMC and labeling expertise?
• Can you support both US and EU submissions in parallel?
• What deliverables are included: gap assessment, agency meeting prep, module authoring, publishing, response writing?

If you want, I can narrow this down

I can give you a shortlist tailored to your product and region if you tell me:

• product type
• US, EU, or both
• development stage
• filing type (e.g., 505(b)(2), NDA, ANDA, DCP, MRP, centralized)
• whether you need strategy, document authoring, publishing, or full submission management

If you share those details, I can recommend the most relevant consultant types and firms.