Services
Our professionals become your experts.

• Prepare, review and assemble marketing submissions to global regulatory authorities for the following product categories:    
  • Drugs, including orphan drug and fast track applications
  • Generic drugs
  • Devices, including diagnostics
  • Biologics
  • Veterinary products
• Liaise with health agencies to resolve issues and expedite marketing approvals
• Provide expert advice on regulatory strategy
• Prepare and implement regulatory Standard Operating Procedures
• Review labeling and advertising
• Prepare, review and assemble investigational applications, including verifying and evaluating documentation
• Work at client sites to handle their day-to-day regulatory operations.  Tasks include but are not limited to:
  • Prepare information and protocol amendments, safety reports and all necessary 
    correspondence to FDA
  • Audit investigator documentation to ensure compliance with 21 CFR 50 and 21 CFR 56 
  • Approve and process shipping orders for investigational use
  • Prepare export documentation for non tier-one countries; assure all appropriate export documentation is in place for tier-one countries
  • Manage labeling changes for USPI, SmPC and Core Data sheet
  • Review study protocols, study reports, and completed CRFs, for submission accuracy/  
    completeness
• Prepare background documents to health authorities
• Prepare/submit Drug Establishment Registration/Renewals and Drug Product Listings
• Manage/input study information in FDA database of investigational protocols for treating serious and life threatening diseases

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•   Prepare, assemble and review CMC sections of human and veterinary investigational and marketing applications filed to global regulatory authorities for:
  • Parenterals, including pre-filled syringes
  • Solid dosage forms
  • Liquids, suspensions and creams
  • Modified release dosage forms
• Prepare, assemble and review sterilization validation documentation for sterile products
• Prepare, assemble and review Drug Master Files
• Prepare stability protocols and stability tables for active pharmaceutical ingredients and drug products
• Write analytical methods and validation reports
• Respond to CMC-related submission queries from US and international health authorities
• Contract and monitor analytical methods development studies
  
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  Periodic and Annual Reports

• Prepare periodic and annual reports for submission to US regulatory authorities. Tasks include:
  • Issuance of the “Call for Information”
  • Collection, review and verification of source data for accuracy
  • Preparation/circulation of draft report
  • Revisions to the report, as necessary
  • Preparation of the appropriate FDA form and cover letter
  • Issuance of the final annual report, FDA form and cover letter for final review and signature
  • Duplication, QC of copies, and submission of FDA and internal distribution copies  

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   United States Agent 

• Represent international companies as the designated US agent; provide general regulatory affairs support, as needed. Tasks conducted on behalf of the sponsor include, but are not 
  limited to:
  • Prepare, review and submit initial IND Applications
  • Prepare, review and submit subsequent amendments (CMC, clinical, pharmaco-toxicological), general correspondence, responses to requests for information, safety reports
  • Prepare and coordinate meetings (pre-IND, end of phase 2, pre-NDA) between sponsor and FDA
  • Assist sponsors in regulatory strategy development and implementation
  • File Orphan drug applications
  • Submit requests to FDA for fast track review
  • Assist in FDA negotiations on preclinical and clinical study requirements
  • Compile, review and submit drug master files and subsequent updates, as required
  • Compile, review and submit original New Drug Applications
  • Coordinate activities to gain FDA approval of marketing applications

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  Quality Control & Assurance

• Carry out comprehensive audits of manufacturing facilities for compliance with current GMPs/FDA regulations and guidelines  
• Prepare and implement Standard Operating Procedures for manufacturing, packaging, labeling and distribution activities  
• Prepare quality control laboratory specifications for:
  • Raw materials
  • Intermediate products
  • Finished products
• Prepare packaging and labeling specifications 
• Serve as the quality control unit responsible for drug product lot release

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