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+1(732) 749-7719 
Your Trusted Partner for Pharmaceutical and Biologics regulatory compliance and approval
For pharmaceutical and biotechnology industries, where regulations are stringent, a well-crafted regulatory strategy is vital for successful market introduction and managing global market intricacies. Since the enforcement of regulatory frameworks, the current era has witnessed significant dynamism from global regulators, demanding up-to-date expertise supported by strong hands-on experience. Our comprehensive service portfolio offers insights and solutions necessary to meet global regulatory requirements, boost compliance, and ensure successful product approvals.
Strategic assistance for Drug development
Accelerate drug development with expert regulatory strategies ensuring compliance and faster market entry.
- Regulatory landscape analysis and strategies for small molecules, biosimilars and novel biologics development
- Regulatory risks identification and mitigation in early drug development
- Due diligence/gap analysis for strategic mergers and acquisitions
- SME support for strategic regulatory agreements/contracts
- Evaluation and resolution of complex scientific and regulatory compliance issues
- Interactions with Health Authorities
- Evaluation of suitability under expedited programs
- End-to-end development and submission of CTAs and related Regulatory documentation
- Scientific advice/meetings with health authorities: strategic drafting and guidance
Submission & Evaluation Phase
Simplify regulatory submissions and evaluations with proven expertise for timely drug approvals for competitive market entry worldwide.
- Drafting and review of dossiers for biosimilars
- Review of dossiers for generics and novels
- CTD/eCTD dossier compilation
- User readability studies
- Regulatory Publishing
- Regulatory Submission
- Drafting and review of responses to health authority queries
Post-approval/Lifecycle management
End-to-end lifecycle management services to maintain compliance and maximize product success post-approval.
- CMC Change control assessment
- Quality Variations/supplements
- Renewals
- Annual reports/notifications
- Line extensions
- Transfer of ownership/MAH
- Safety labeling updates
- Efficient tracking of submissions
Health authority specific services
Tailored regulatory solutions for FDA and EMA to ensure smooth approvals and compliance.
- US FDA
- Pre-IND/IND
- NDA
- ANDA
- BLA
- RFI responses
- CBE
- PAS
- REMS regulatory support
- EMA
- IMPD
- EU-CTIS submission of Clinical Trial Applications
- Eligibility Request Submission
- Letter of intent and scheduling
- MAA
- Responses to LOQ and LoOI
- Environmental Risk Assessment
- Support in Notified Bodies application
- Niche Regulatory submissions
- Pediatric Study Plans (PSP)
- Special Protocol Assessment
- Fast Track Designation
- Orphan Drug Designation (ODD)
- Breakthrough Therapy Designation (BTD)
- PRIME application to EMA
Regulatory representation
Advanced regulatory affairs services for complex products, niche markets, and challenging compliance needs
- Legal/local representative service
- US Agent Nomination & Deputation
- EU/Non-EU QPPV Services
- EU QP Services
- Regulatory FTEs (Resource Provision)
Biosimilar CMC expertise
Trusted CMC expertise for biosimilars, ensuring quality, regulatory compliance, and successful submissions.
- CMC Regulatory intelligence
- CMC strategy
- Regulatory support in product development strategy
- CMC consultation
- CMC writing and review
- Responses to CMC queries
- Review of comparability, similarity and interchangeability studies
Labelling & Artwork Management
Streamline Labelling & Artwork Management for Compliance and Efficiency
- Drafting SmPC, PILs, PIs, Medication Guide
- Investigational Brochures (IB)
- Company Core Data She
Who We Serve?
Biologics
Biosimilars
Generics
NCEs
People
In-house Team of Regulatory Experts and International Regulatory Contact Points
Capabilities
Experience in Range of Products Medicine- Generic/Branded, Biologics, Biosimilars, Combination Products
Platforms
Inhouse eCTD Publishing Tool & SAS
Solution
Whole Lifecycle: From Product Development till Post-Approval & Divestment
Clientele
Global reach, collaborating with diverse clients worldwide
Volume Supported
3896 xEVMPD entries, 1400+ eCTD Publishing, 360+ query responses, 50+ moderate and minor variations, 36 Safety Labelling Changes, 15 scientific advices, 8 Major variations, 04 Biologics MAA, 07 CT Application, 300+ MA Transfer & multiple renewals
Request for Proposal
Ready to streamline your regulatory journey? Contact us today for pharmaceutical regulatory consulting and biosimilars compliance solutions.
FAQs
Biosimilar submissions require additional scientific evidence, including comparability, similarity, and interchangeability studies, to demonstrate that the product matches the reference biologic in safety and efficacy. Generics, by contrast, typically rely on bioequivalence data rather than the more complex CMC (Chemistry, Manufacturing, and Controls) and analytical comparability work biosimilars demand. This is why biosimilar programs often need specialized CMC regulatory expertise that goes beyond standard generic drug submission support.
Yes. COD Research helps sponsors evaluate eligibility and prepare applications for accelerated pathways including Orphan Drug Designation (ODD), Breakthrough Therapy Designation (BTD), and Fast Track Designation. Since each pathway has distinct qualifying criteria and evidence requirements, sponsors benefit from early regulatory strategy input to determine which designation best fits their product and development stage.
Yes. With experience spanning US FDA, EMA, and other global health authority frameworks, COD Research supports sponsors running parallel or sequential submissions across regions rather than treating each market as a separate, disconnected process. This is particularly valuable for companies pursuing simultaneous market entry in the US and Europe, where dossier requirements and review timelines differ but submission strategy needs to stay coordinated.