Regulatory consultants and lawyers for regulatory submissions, filings, applications, registrations, amendments, accreditations, amendments, approvals, licensures, reports, filings, dossiers, import tolerances, and certifications such as FDA New Drug Approvals, CMC Sections, NDA, Electronic Submissions, New Chemical Entities, Biologics License Application BLA, Investigational New Drug IND, Abbreviated New Drug Approvals ANDA, Annual Reports, Pre-Market Approvals, PMA, 510ks, Drug Master Files, DMF, EU Common Technical Documents, CTD, etc. Submit Regulatory Request

Regulatory consultants and attorneys for the evaluation of compliance to international government regulations, laws, guidelines, internal standard operating procedures, and industry standards.Regulatory Consulting and legal services for compliance to standards, laws, regulations, and guidelines such as US FDA FD&C, SUPAC, Good Manufacturing Practices, GMP, ICH, GLP, GCP, ISO, QSR, HAACP, Annual Reports, Adverse Drug Experience Reporting, Dangerous Preparations Directives, Part 11, EU Directives, IEEE, ASTM, EU Directives, MDD, IVDD, Health Canada, Australia TGA, etc. Submit Regulatory Request

Consultants and Auditors for Internal and external audits including development and review of Internal and External Audit Programs, due diligence or internal assessments, or external supplier vendor qualification audits in industries.Audits such as US Food & Drug Administration (USFDA) Good Manufacturing Practices (GMP) audits, ICH GCP audits, QSR Audits, Good Laboratory Practices audits, CLIA Audits, mock US FDA inspections, Vendor Audits, Clinical Monitoring, ISO audits, supplier audits, HAACP audits, etc Submit Regulatory Request

Quality Consultants for development, implementation, review, and interim management of Quality Systems. Consulting includes such services as US Food & Drug Administration (USFDA) Good Manufacturing Practices GMP, QSR, ISO, quality systems, quality assurance and quality control (QA & QC) quality plans and quality standard operating procedures such as Failure Investigations, Change Control, Design Controls, Manufacturing Controls, Document Controls, Recordkeeping, Software Quality Assurance, Quality Audits, Quality Manuals, CAPA, etc.Submit Regulatory Request

Regulatory Consultants and Attorneys for government relations. For consulting such as US Food and Drug Administration, US Environmental Protection Agency, Health Canada, Therapuetic Goods Agency, EMEA, etc. Regulatory Consulting and Legal Services for Government relations includes regulatory agency meetings, notified bodies, designated agents, US agents, faciliation of inspections, remediation, compliance meetings, etc.Submit Regulatory Requests for Proposals

Consulting for in-house, off-site, or on-line techical, manufacturing, legal, scientific and business education and training programs, courses, webinars, workshops, conferences, workshops, and seminars such as Good Manufacturing Practices GMP, Good Laboratory Practices GLP, GCP, ISO, Common Technical Documents, Part 11, Validation, EMEA, Quality Systems, FDA Inpsections, Annual Reviews, Change Control, Failure Investigations, Regulatory Submissions, Water Systems, Part 11, Compliance, Design Controls, Clinical Monitoring, Documentation Systems, Electronic Records, Aseptic Processing, Sterilization, etc.. Submit Regulatory Request

Medical, Scientific and Technical reviews for regulatory submissions, research and development, expert witnesses, product development, technology transfer, legal cases, etc. in areas such as pharmacology, pharmacokinetics, microbiology, toxicology, product safety, proteomics, protein sciences, genomics, biochemistry, statistics, feasibility, mathematics, facility design, computer sciences, software design, automation, bioengineering, sterilization, engineering, water systems, hematology, laboratory testing, manufacturing, bioprocessing, packaging, aseptic processing, polymers, advanced materials, nanotechnology, nuclear sciences, electronics, biomechanics, oncology, immunology, etc.Submit Regulatory Request

Validation Consultants and Validation Engineers for development, design, management, review, and implementation of Qualification and Validation Programs. Qualification and Validation Consulting and Engineering includes equipment qualification ( IQ, OQ, PQ), Cleaning Validation, Methods Validation, Process Validation, Design Validation, Water System Validations, Packaging Validations, HPLC Validations, Lyophilization Validations, Mixing Validations, Software Validation, Electronic Records, and Computer Validation (Part 11), etc. Submit Regulatory Request

Development, design and compliance reviews of Labeling, Packaging, Advertising and Promotional Materials. Submit Regulatory Request