»ÆÈ˵¼º½

Product Lifecycle Services

RCA’s expertise in pharmaceuticals extends to existing products on the market. We can help with regulatory strategy and dossier content management throughout your product’s entire lifecycle, including the following:

• Annual Reports and Periodic Adverse Drug Experience Reports (PADERs)
• Changes Being Effective: CBE-0 and CBE-30 Supplements
• Prior Approval Supplements (PAS)
• Abbreviated New Drug Application (ANDA)
• Amendments
• Changes to Supplier Sourced Material
• Changes to Meet New Agency Publishing Requirements
• Type I and Type II Variations (EU)

Our broad range of »ÆÈ˵¼º½ Regulatory Affairs consulting services include:

• New Product Support
• Product Lifecycle Management
• Other Regulatory Services

To begin the Regulatory Compliance »ÆÈ˵¼º½ scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.ÌýYou may also email us at [email protected].