Regulatory Compliance Engine

Built-in, mandatory, and comprehensive

Compliance: The Foundation, Not an Afterthought

pharma.avermex.com isn't just a discovery tool—it's a compliance platform. Every molecule analyzed is automatically validated against multiple regulatory frameworks to ensure research stays within legal and ethical boundaries.

Our Principle: If a candidate can't pass regulatory review, it shouldn't waste your R&D budget. We validate compliance at every step, not after millions have been spent.

Supported Regulatory Agencies

FDA (United States)

Food and Drug Administration

Validation Coverage:

  • IND (Investigational New Drug) requirements
  • Orange Book exclusivity checks
  • GRAS (Generally Recognized as Safe) database
  • Drug Master File (DMF) format compliance
  • 21 CFR Part 211 (GMP regulations)
  • ICH guidelines (E6, E8, E9 for clinical trials)

Referenced Databases:

  • FDA Approved Drug Products
  • FDA Adverse Event Reporting System (FAERS)
  • FDA Inactive Ingredient Database
  • CDER Drug Safety Communications

COFEPRIS (México)

Comisión Federal para la Protección contra Riesgos Sanitarios

Validation Coverage:

  • Ley General de Salud compliance
  • NOM-059-SSA1 (Good Manufacturing Practices)
  • NOM-073-SSA1 (Stability of drugs and medications)
  • Registro Sanitario requirements
  • Farmacopea de los Estados Unidos Mexicanos
  • Third-party manufacturer authorization

Referenced Regulations:

  • Ley General de Salud, Título Duodécimo
  • Reglamento de Insumos para la Salud
  • Mexican Pharmacopoeia standards
  • COFEPRIS resolution archive

EMA (European Union)

European Medicines Agency

Validation Coverage:

  • CHMP guidelines (Committee for Medicinal Products)
  • Ph. Eur. (European Pharmacopoeia) compliance
  • Orphan drug designation criteria
  • Centralized authorization procedure
  • EMA guideline database
  • Pediatric investigation plans (PIPs)

Referenced Databases:

  • EudraVigilance (adverse reaction reporting)
  • EU Clinical Trials Register
  • European Pharmacopoeia standards
  • Community register of medicinal products

Note: EMA validation available in Professional and Enterprise tiers.

5-Stage Validation Process

Every molecule passes through all stages automatically. No opt-out, no shortcuts.

1

Scaffold Validation

Automated Checks:

  • FDA scaffold library comparison
  • PAINS filter (Pan-Assay Interference Structures)
  • Structural alert screening (Brenk, NIH)
  • Reactive functional group detection
  • Drug-like filter (Ghose, Veber, Egan)
Output: Pass/Fail with detailed warnings
2

Property Analysis

Pharmacokinetic Rules:

  • Lipinski's Rule of Five (oral bioavailability)
  • Veber's rules (rotatable bonds, TPSA)
  • Ghose filter (drug-likeness)
  • Blood-brain barrier permeability (CNS drugs)
  • Solubility prediction (LogS)
Output: Compliance score + recommendations
3

Toxicity Prediction

Safety Assessments:

  • Ames mutagenicity (bacterial reverse mutation)
  • hERG liability (cardiac ion channel blockage)
  • Hepatotoxicity markers (liver damage)
  • Carcinogenicity prediction
  • Skin sensitization (Derek alerts)
Output: Risk classification + mitigation strategies
4

Legal Validation

Intellectual Property:

  • Prior art search (USPTO, EPO, WIPO)
  • Active patent identification
  • Patentability analysis (novelty, non-obviousness)
  • Freedom-to-operate assessment
  • Exclusivity period tracking
Output: Patent landscape report + FTO status
5

Synthesis Feasibility

Manufacturability:

  • Starting material commercial availability
  • Reaction condition feasibility
  • Scale-up complexity analysis
  • Cost-per-gram estimation
  • GMP compatibility check
Output: Synthesis route + feasibility score

Our Guarantee

If a molecule reaches your final report, it has passed all regulatory checks for the jurisdictions you've selected. You can proceed with confidence that fundamental compliance requirements have been met.

Legal Analysis Features

Prior Art Search

Automatic search across USPTO, EPO, WIPO patent databases and scientific literature (PubMed, PubChem, ChEMBL) to identify existing patents and publications that may affect patentability.

Search Coverage:

  • Structure-based similarity search (Tanimoto > 0.85)
  • Substructure exact match
  • Pharmacophore-based search
  • Full-text publication search
  • CAS Registry Number lookup

Patentability Analysis

Evaluates novelty, non-obviousness, and utility of candidate molecules according to patent law standards (35 U.S.C. §§ 101-103). Generates preliminary claim drafts for patent attorney review.

Analysis Components:

  • Novelty assessment (§102 analysis)
  • Non-obviousness evaluation (§103 KSR test)
  • Utility demonstration (§101 compliance)
  • Claim scope optimization
  • Preliminary claim draft generation

Freedom-to-Operate (FTO)

Identifies active patents that may restrict commercial use of a compound in specific territories. Includes expiration date tracking and litigation history where available.

FTO Assessment:

  • Active patent identification by territory
  • Claim construction analysis
  • Infringement risk scoring
  • Expiration date forecasting
  • Licensing opportunity identification

Why Compliance Cannot Be Disabled

Unlike other platforms that treat compliance as an optional add-on, we've made regulatory validation mandatory and non-negotiable for ethical and practical reasons:

Ethical Responsibility

Pharmaceutical research affects human health. Enabling researchers to bypass safety checks would be ethically irresponsible and potentially dangerous.

Waste Prevention

The average cost to develop a drug that fails in clinical trials is $1-2 billion. Early compliance validation prevents expensive late-stage failures.

Legal Protection

By ensuring every output has passed compliance checks, we protect both you and Avermex from potential liability issues.

Quality Assurance

Mandatory compliance creates a quality floor. You can trust that any molecule in your results meets minimum regulatory standards.

Experience Compliance-First Discovery

See how built-in regulatory validation accelerates research while ensuring safety.

Try Free Demo Schedule Consultation