A. US FDA Regulatory Submissions (From concept to Product Approval)

• Premarket Notification (510(k))
• Investigational Device Exemptions (IDE)
• Premarket Approval (PMA) 
• Investigational New Drug Application (IND)
• New Drug Application (NDA) 
• Abbreviated New Drug Application (ANDA)
• Biologic License Application (BLA)

B. Regulatory Compliance 

• Regulatory compliance cGMP, GCP and GLP (GXP).
• How to implement FDA’s Risk Management Program. 
• Experience in Companywide Initiation and organization of the Risk Management Program including preparing the “Risk Charter”, “Risk Quantification”, “Risk Analysis”, “Risk List” and introducing Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) approach. 
• Quality Audits and Corporate Regulatory Compliance Audits (SOP’s, HPLC, GC, GLP, Clinical site).
  • Quality Agreement, Vendor Relations Program, Vendor Certification, Vendors Audits and Vendor Rating System.
  • Improve Quality and Productivity through Six Sigma.
  • System Audit on Technical Development group and Technical Product Complaints for FDA Regulatory Compliance (CAPA).
  • Experience in Setting up the entire documentation system, audit for compliance and update (e.g. ”Standard Operating Procedures”, “Plant Master File”, “Master Device Record”, Device History Record”).
  • Experience in Complaint Handling System (CAPA) and Trend Analysis, Trouble Shooting and finding Assignable Cause.
  • GAP Analysis, Companywide Implementation of ISO 13485.
  • Companywide implementation of simplified “Statistical Process Control Program” including non-manufacturing areas like Accounting, Human Resources. 
• Extensive knowledge in FDA Product Recall Procedures and Process Failure Investigation.
• Quality System Regulations (QSR). 
• Helping manufacturers prepare for a pre-approval inspection (PAI) in pharmaceutical drugs, biologics, medical devices, in vitro diagnostics. Find out whom to look to for answers to your questions and queries in FDA system. Prepare answers to FDA questions. Prepare inquiries to FDA for answers to your specific questions. Evaluate Adverse Reaction and Severe Adverse Reaction Reports and submission to FDA. Professional Development /Training courses are also available for US Regulatory Affairs 
• For example: 510 (k) / PMA / IND / BLA / ANDA / NDA / Supplements / Annual Report / ADE / Biological Product Deviations / Regulatory Compliance/ QSR/ FDA’s Risk Management Program.

C. International Regulatory Affairs

• Experience in international registrations with FDA approved products in the following countries:
• China, Taiwan, Thailand, Malaysia, India and Japan. 
• A team of highly qualified individuals who have proven track record in Indian regulatory processes will take care of all your company’s Indian regulatory affairs needs. Free Sale Certificate, Export Permit, Import Permit.
• Foreign Drug Manufacturer Registration and Listing and Medical Device registration, listing 
• Identify communicate and qualify vendors/suppliers of Active Pharmaceutical Ingredients (APIs)