Today’s protocols require a global scope in order to supply clinical materials to patients around the world. In order to comply with regulatory requirements for each area targeted in the protocol, clinical leads must analyze and supply documentations to comply with local laws. As protocols increase in scope, regulatory requirements represent a major source of trial delays or failures. A strategic partner is required to manage regulatory success and ensure smooth protocol progression.

Ancillare provides regulatory compliance services to ensure that all requirements are met in advance of launching a new protocol. Through our extensive track record, Ancillare holds the expertise needed to provide documentations and products to exceed regulatory specifications. Our teams help manage supply chain partners to ensure that compliance is maintained at all protocol levels. Our reporting services provide clinical leads with detailed records to illustrate global protocol success. By working as a vested partner, Ancillare ensures that all regulatory requirements are met and that protocols progress smoothly without delay from failure to meet compliance throughout the world.

Ancillare can become your strategic partner to ensure global regulatory compliance and smooth protocol progression for any therapeutic area requirements.

Our proven services include:

	Global regulatory compliance support with labels and supporting product documentation to meet EU, EC, and WHO Annex 13 Guidelines
	Extensive hands-on experience, knowledge and full command of Global U.S, EU, EC, WHO, EMEA, Chinese and India Ministry of Health requirements, laws, regulations and guidances
	Regulatory affairs, quality control, quality assurance, drug discovery, CMC, preclinical, and clinical materials, and ancillary supplies
	U.S. and Global regulatory guidance and provision over the spectrum of pharmaceutical, biotech drug development, medical devices and commercialization for all products and therapeutic areas
	Assistance with filing, registration and approval of new and existing products in accordance with sponsor’s business objectives
	Assistance with regulatory strategies to address trends and changes in International and US regulations
	Support to Global Franchise and local markets in the regulatory review of labeling, Instruction for Use, promotion and advertising materials
	Provide CFR, EU, EC, WHO, ICH Q7, ISO Regulatory Compliance, Labeling, Change Monitoring and Notification Services
	Internal and External CGCP, CGMP, CGLP Quality and Regulatory Compliance Audits.
	Records keeping and maintenance per protocol and regulatory specifications

Ancillare is able to work successfully within a clinical team environment and as an individual contributor, decision maker and leader to ensure that a project is a success. Our expertise can provide you with the tools needed to implement complex global protocols in all regions and therapeutic areas.