Regulatory & Compliance Consulting
Consultancies guiding manufacturers through regulatory submissions, labeling, pharmacovigilance, and compliance programs.
15 vendors listed
Regulatory and compliance consultancies help manufacturers navigate the complex regulatory landscape from pre-IND through post-market. They ensure therapies meet FDA/EMA requirements and that commercial activities comply with applicable laws.
Core Services
- Regulatory Strategy: NDA/BLA submission planning, breakthrough/fast track/accelerated approval pathways
- FDA/EMA Submissions: Writing, formatting, and managing regulatory submissions
- Labeling & Promotional Review: USPI development, promotional material review (PRC/MRC support)
- Pharmacovigilance: Adverse event reporting, REMS management, signal detection
- Compliance Programs: Sunshine Act reporting, anti-kickback compliance, state transparency
Veeva Systems
Pleasanton, California
Veeva Systems is the dominant cloud software and data vendor serving the global life sciences industry.
Accreditation Commission for Health Care
Cary, NC
Nationally recognized accreditation empowering healthcare providers with quality standards, education, and CMS compliance for excellence.
- Collaborative/educational survey approach (vs punitive)
- Tailored standards for small/mid-sized providers
- Strong customer service with dedicated advisors and resources
BioCare
Tempe, Arizona
Leading specialty pharma distributor delivering life-saving therapies with 24/7 support, rapid distribution, and integrated 3PL for manufacturers.
Duane Morris
Philadelphia, Pennsylvania
Global legal counsel accelerating pharma innovation through IP, regulatory, and transactional expertise across product lifecycles.
- Attorneys with pharma in-house/scientist backgrounds
- Top PTAB success rate and ANDA defense firm
Frier Levitt
Pine Brook, NJ
Exclusive healthcare law firm empowering providers and pharmacies with regulatory, transactional, and litigation expertise.
- Exclusive focus on healthcare/life sciences/pharmacy law
- attorneys who are licensed clinicians/pharmacists
- deep expertise in PBM disputes and pharmacy regulatory issues
Holland & Knight
Tampa, Florida
Leading legal experts guiding pharma and specialty pharmacy through regulatory, reimbursement, and transactional challenges.
- Largest U.S. healthcare law practice (400+ attorneys)
- multidisciplinary teams with in-house pharma/pharmacy experience
LighthouseAI
Los Angeles, CA
AI-powered state licensing software and services automating pharma supply chain compliance across all US jurisdictions.
Medpro
Mount Arlington, NJ
Authoritative HCP/HCO data and compliance platforms empowering life sciences to launch and scale with precision.
- Most accurate/comprehensive real-time HCP/HCO data from authoritative sources
- end-to-end global transparency platform with single sign-on
- 25+ years experience with proactive, personalized service from industry veterans
National Association of Specialty Pharmacy
Washington, DC
Premier trade association unifying all specialty pharmacy stakeholders through education, CSP certification, advocacy, and the annual inSPire conference.
- Only national association representing all SP stakeholders
- Certified Specialty Pharmacist (CSP) credential via SPCB
- 200+ corporate members across the SP ecosystem
NCODA
Cazenovia, NY
Empowering medically integrated oncology teams with accreditation, standards, and resources for optimal oral oncolytic care.
- First/only accreditation for medically integrated oncology pharmacies
- ASCO/NCODA quality standards published in JCO
- focus on MIP model excluding PBM mail-order via OOLD advocacy
PBMSource
Phoenix, Arizona
Streamlined SaaS compliance platform automating PBM regulatory tracking, reporting, and licensing nationwide.
- - Centralized "
- one source"
- dashboard for all PBM compliance needs.&10
PharmaLink
Largo, Florida
Nation's premier reverse logistics provider maximizing returns credits and ensuring compliance for pharma supply chain partners.
- Encore web-based reporting platform for real-time analytics and transparency
- VAWD-accredited with full DEA/FDA compliance including controlled substances
- Tailored solutions with on-site service and maximum credit recovery across supply chain segments.
Thermco Products
Lafayette, New Jersey
Precision temperature monitoring and calibration solutions for pharma cold chain, vaccines, and lab compliance worldwide.
- ISO/IEC 17025 accredited calibration lab
- VFC-approved vaccine products
- 50+ years family-owned precision manufacturing
URAC
Washington, DC
Independent accreditor validating healthcare quality and accountability through rigorous, evidence-based standards for pharmacies, providers, and innovators.
- Rigorous, collaborative process with customized roadmaps and public gold star seal
US Drug and Device Register
Scottsdale, AZ
Bridging manufacturers to US healthcare payers, providers, and channels for profitable market access and growth.