Faster market entry. Stronger portfolios. Global pharma made simple
Enabling confident global entry and portfolio growth for pharma companies.
We offer ready-to-use dossiers, active MAs, out-licensing, and downloadable templates—including checklists and regulatory documents—as well as regulatory solutions to streamline your market entry and portfolio development. Whether you’re a newly launched, small, or well-established pharmaceutical company, contract manufacturing organisation, or research institution, we provide the tools and expertise to help you navigate complex regulatory landscapes with confidence.
Our Comprehensive Services
We deliver end-to-end regulatory solutions to accelerate your global pharmaceutical market entry with confidence and compliance.
Pharma Solutions Overview
Explore our full portfolio of regulatory, manufacturing, and commercialization services—tailored to accelerate your pharmaceutical journey from concept to market.
Dossier Development & Sales
Marketing Authorisation Transfer
Start a Pharmaceutical Company
Benefit from expert guidance to navigate regulatory requirements from day one. Build a strong foundation for your pharmaceutical venture.
Compliance Templates & Forms
Ready-to-use templates for SOPs, QMS, validation, and pharmacovigilance. Stay audit-ready and save time.
Quality and Supply Management
Ensure consistent product quality and uninterrupted supply through our integrated oversight of manufacturing, logistics, and QA processes.
Each service is delivered with meticulous attention to detail and a commitment to your success.
Great service isn’t just our promise—it’s our standard.
Dossiers with Exclusive Offers
Explore our spotlight selection of high-demand pharmaceutical dossiers—ready for licensing and tailored to strategic market needs.
Diclofenac Gel
- Strengths: 1% and 5%
- Therapeutic Area: Topical anti-inflammatory
Piperacillin Tazobactam
- Strength: 4.0g / 0.25g vial
- Therapeutic Area: Broad-spectrum antibiotic injection
Cefuroxime Injection
- Strengths: 0.25g / 0.75g / 1.5g
- Therapeutic Area: Cephalosporin antibiotic
Meropenem Injection
- Strengths: 0.5g / 1.0g
- Therapeutic Area: Carbapenem antibiotic
Irinotecan Injection
- Strength: 20 mg/ml
- Therapeutic Area: Oncology / Chemotherapy
Enalapril Tablets
- Strengths: 2.5 / 5 / 10 mg
- Therapeutic Area: ACE Inhibitor for hypertension
Atorvastatin Tablets
- Strengths: 10 / 20 / 30 / 40 / 60 / 80 mg
- Therapeutic Area: Cholesterol-lowering agent
Aspirin Paracetamol Caffeine Tablets
- Strengths: Combination
Note: (now bibliographic EU application)
Azithromycin Tablets
- Strengths: 250 mg & 500 mg
- Therapeutic Area: Macrolide antibiotic
Ceftriaxone Injection
- Strengths: 1.0g / 2.0g
- Therapeutic Area: Cephalosporin antibiotic
Ceftazidime Injection
- Strengths: 0.5g / 1.0g / 2.0g
- Therapeutic Area: Cephalosporin antibiotic
Our Regulatory Expertise at Your Service
Our experts bring decades of combined experience working with regulatory authorities worldwide, including the FDA, EMA, MHRA, and many emerging market regulators. Good service can be found anywhere, but great service is our commitment to you.
1. Strategic Regulatory Consulting
Services designed to help navigate the complex and ever-changing global regulatory landscape with confidence.
2. Submission Management
End-to-end handling of regulatory submissions across multiple jurisdictions, including preparation, publishing, and response to authority queries.
3. Post-Approval Compliance
Ongoing support for maintaining regulatory compliance, including variation management, periodic safety updates, and renewal applications.
4. Regulatory Intelligence
Stay ahead with our monitoring and analysis of global regulatory developments that may impact your products and strategic planning.
Looking for a specific dossier?
Our dossier portfolio includes over 200 CTD-formatted dossiers across all major therapeutic areas and dosage forms. If you're searching for a specific product or need tailored documentation, our regulatory team is here to assist.