Applications Specialists International, Inc - Regulatory Affairs, Quality Assurance & Technical Services - Services

 Pharmaceutical Products & Services

Services

Specific services that are offered include:

• Preparation and submission of NDAs, ANDAs, BLAs, DMFs and supplements to existing applications
  
• Assisting the client in responding to any questions from FDA during the review process
  
• Writing and assembly of the CMC sections for submissions including INDs
  
• Acting as a liaison (or agent) with the FDA for the client in setting up meetings to discuss new facilities, new applications, technical issues, etc
  
• Assisting clients in preparing for pre-approval inspections (PAIs)
  
• Performing GMP compliance audits on the client's facilities, contract laboratories, contract manufacturers of drug substances, excipients or finished product
  
• Offering Quality Assurance/Quality Control assistance by writing SOPs, advising on upgrading of testing laboratories, auditing labs for deficiencies, providing consultation on method validation
  
• Assisting clients in bringing their facilities into GMP compliance. Advising clients who have had FDA inspections resulting in 483s, Warning letters, etc., on how to respond to the FDA, and how to best bring their deficiencies into compliance
  
• Providing guidance on thermal validations of equipment such as ovens, refrigerators, stability incubators, sterilizers, infrared tunnels, etc
  
• Additionally, providing guidance in the validation of steam sterilizers (both thermal and micro)

With this experience and expertise, while our services are primarily focused in the areas of regulatory and quality assurance, several companies have been advised on technical issues in QA, manufacturing and R&D.

Advantages of Applications Specialists International, Inc

• A consultant "who has been there" and performed these same tasks first hand, not some large organization that only gives you a general, vague direction or answer
  
• A consultant who will devote the time and attention to your project, and provide personalized attention
  
• A consultant, who keeps abreast with the current regulations, and who will also use necessary resources to seek solutions to your needs
  
• A consultant who is flexible to come "on-site" and work directly with your people as necessary, to accomplish the task(s) and save time in the process
  
• Close proximity to the FDA, since the company is located in North Carolina

Applications Specialists International has worked closely with clients of all types and sizes, from virtual companies to small biotechs to medium sized and big pharmaceutical companies.

We have aided start-up companies set up documentation systems and write SOPs for their needs. We have helped medium sized companies with the redesign of API facilities to be GMP compliant and large pharmaceutical companies have outsourced various projects to save time and resources internally. Contract manufacturers have also used us to help validate steam sterilizers.

Small as well as brand name companies have been clients of Applications Specialists International to review applications, write sections of their applications and completely assemble and submit applications.

If you'd like to find out how we can help you, why not give us a call or fill in our contact form.

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	Applications Specialists International, Inc
	109 Shore Drive Garner North Carolina 27529 USA
Tel.	+1 919 772 8518
Fax	+1 919 772 1300