Oridin Group | Pharmaceutical Consulting

Oridin Group provides pharmaceutical consulting services to federal agencies and primes across clinical research, regulatory strategy, quality systems, manufacturing scale-up, and program management. We maintain active SAM registration and align to FAR/DFARS requirements, with clear NAICS mapping and a dedicated contracting point of contact.

Small Business (SB)
Minority-Owned
U.S.-based, federal contracting ready

541611, 541613, 541690
541714, 541715, 541380
541512, 325412,

Download Capabilities Statement (PDF)

12ORIDIN UEI

TBD-123 CAGE Code

Active SAM Status

541690 Primary NAICS

- Capabilities

Clinical Trial Operations

Clinical Trial Operations Execution of early- and late-phase clinical trials including protocol development, site activation, and data capture.

Investigator Site Management

Investigator Site Management Oversight of clinical sites including training, monitoring, and regulatory documentation support.

Safety Monitoring & Reporting

Safety Monitoring & Reporting Medical monitoring, SAE reconciliation, and pharmacovigilance aligned with FDA and ICH standards.

Regulatory Strategy & Dossier Prep

Regulatory Strategy & Dossier Prep Development of global regulatory strategy and authoring of CTD modules for FDA, EMA, and rest-of-world submissions.

FDA/Agency Meeting Support

FDA/Agency Meeting Support Preparation of briefing documents, Q&A, and engagement strategy for Type B/C and advisory committee meetings.

Labeling & Promotional Review

Labeling & Promotional Review Development and review of labeling and promotional content compliant with 21 CFR and OPDP standards.

Tech Transfer & Scale-Up

Tech Transfer & Scale-Up Support for technology transfer to manufacturing partners and scale-up of clinical or commercial processes.

PPQ & Process Validation

PPQ & Process Validation Planning and execution of process qualification protocols and reports for drug substance and drug product.

Cold Chain & Controlled Shipping

Cold Chain & Controlled Shipping Design and qualification of temperature-controlled shipping systems for public-sector depot delivery.

Government Market Entry Planning

Government Market Entry Planning Roadmap for entering the federal market, including pricing, contract vehicles, and stakeholder mapping.

Teaming & Proposal Strategy

Teaming & Proposal Strategy Support for building prime/sub relationships, small business utilization, and proposal win themes.

Public Health & Emergency Readiness

Public Health & Emergency Readiness Strategy for pandemic and SNS-aligned programs (e.g., BARDA, ASPR) including surge supply chain modeling.

cGMP Quality Systems

cGMP Quality Systems Design and optimization of SOPs, batch records, and CAPA systems to support regulatory inspections.

Analytical Method Validation

Analytical Method Validation ICH-compliant method validation for release, stability, and cleaning methods across multiple modalities.

Stability Program Management

Stability Program Management Design and monitoring of stability protocols in line with ICH Q1A and agency expectations.

Federal Contract Compliance

Federal Contract Compliance Support for compliance with FAR, DFARS, Section 889, and relevant agency-specific procurement rules.

CUI & Cybersecurity Compliance

CUI & Cybersecurity Compliance Implementation of NIST 800-171 and CMMC-aligned controls for handling Controlled Unclassified Information.

Proposal Development & Cost Volumes

Proposal Development & Cost Volumes Turnkey RFP/RFI/RFQ response development including cost narratives, compliance matrices, and volume writing.

- Contact Us

Reach out for scientifically sound, market-ready guidance—delivered with precision and ingenuity.

Mail Us

Email info@oridingroup.com

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- Write Us