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Qual Conform’s pharmaceutical regulatory experts develop winning strategies tailored to your drug development program:
– Regulatory landscape assessments and gap analyses
– Drug classification and submission pathway determination (NDA, ANDA, 505(b)(2))
– Pre-IND and pre-NDA meeting strategy and preparation
– Design and implementation of nonclinical and clinical development plans
– Orphan drug designation and fast track designation support
Qual Conform provides comprehensive CMC guidance:
– CMC strategy development and gap analysis
– Formulation development and optimization support
– Analytical method development and validation
– Stability testing program design
– Manufacturing process development and scale-up guidance
– Vendor and contract manufacturing organization (CMO) selection support
Qual Conform assists in planning and executing nonclinical studies:
– Nonclinical study design and protocol development
– Good Laboratory Practice (GLP) compliance support
– Toxicology program planning
– Pharmacology study design and interpretation
– Nonclinical data analysis and reporting
Qual Conform’s IND experts ensure thorough submissions:
– IND application preparation and submission
– Pre-IND meeting request and briefing document preparation
– IND maintenance and amendment support
– Clinical hold response assistance
Qual Conform guides you through clinical study requirements:
– Protocol development and review
– Investigator’s Brochure (IB) preparation
– Clinical trial application support for global studies
– Data Safety Monitoring Board (DSMB) charter development
– Clinical study report preparation
Qual Conform manages complex NDA submissions:
– NDA application strategy and planning
– Electronic Common Technical Document (eCTD) compilation
– Clinical data analysis and presentation
– Label development and negotiation
– Advisory committee meeting preparation and support
Qual Conform’s ANDA experts navigate the generic drug approval process:
– Bioequivalence study design and protocol development
– ANDA submission preparation and filing
– Paragraph IV certification strategy and support
– Patent challenge and exclusivity analysis
Qual Conform guides you through the 505(b)(2) pathway:
– Gap analysis and development plan optimization
– Nonclinical and clinical bridging strategy
– Comparative bioavailability and bioequivalence study design
– 505(b)(2) application preparation and submission
Qual Conform helps establish robust QMS aligned with FDA requirements:
– 21 CFR Parts 210 and 211 (cGMP) compliance
– ICH Q10 Pharmaceutical Quality System implementation
– Quality by Design (QbD) and Process Analytical Technology (PAT) integration
– Standard Operating Procedure (SOP) development and implementation
– Batch record review and release process optimization
Qual Conform ensures robust validation processes:
– Validation master planning
– Process validation (including continued process verification)
– Cleaning validation
– Computer system validation
– Analytical method validation
– Equipment qualification (IQ/OQ/PQ)
Qual Conform prepares you for regulatory scrutiny:
– Mock FDA inspections (cGMP, GCP, GLP)
– Gap analysis audits
– Supplier and CMO audits
– FDA inspection readiness and support
– FDA 483 and Warning Letter response assistance
Qual Conform supports your product throughout its lifecycle:
– Post-approval change management
– Annual report preparation and submission
– Supplemental NDA (sNDA) and CBE-30 submission support
– Product discontinuation and withdrawal support
Qual Conform helps maintain ongoing safety monitoring:
– Pharmacovigilance system design and implementation
– Adverse event reporting and management
– Periodic safety update report (PSUR) preparation
– Risk evaluation and mitigation strategy (REMS) development and updates
Qual Conform assists in maintaining and improving compliance:
– cGMP compliance assessments and gap analysis
– Remediation plan development and implementation
– Quality metric reporting support
– Consent decree and corporate integrity agreement (CIA) compliance
Qual Conform supports your international expansion:
– Global regulatory landscape assessment
– International regulatory strategy development
– Common Technical Document (CTD) preparation for multiple markets
– European Medicines Agency (EMA) and other health authority submission support
Qual Conform helps maintain ongoing safety monitoring:
– Pharmacovigilance system design and implementation
– Adverse event reporting and management
– Periodic safety update report (PSUR) preparation
– Risk evaluation and mitigation strategy (REMS) development and updates
Qual Conform assists in maintaining and improving compliance:
– cGMP compliance assessments and gap analysis
– Remediation plan development and implementation
– Quality metric reporting support
– Consent decree and corporate integrity agreement (CIA) compliance
Learn more about International Regulatory Services