cGXP (GMP / GLP / GCP) Audits
		cGXP Compliance (Quality Systems, SOPs, and Record Keeping)
		Preparation and / or Review of Regulatory Submissions
		Validation and Analytical Support Services
		Support Services for Preclinical / Clinical / Bioequivalence Studies
		Quality, Non-clinical and Clinical Summaries / Expert Reports
		Regulatory Affairs Representation and Liaison Services

PharmAlliance provides comprehensive advice on international regulatory compliance requirements for your facilities and operations, develops and implements systems and procedures that will ensure that your facilities comply fully with cGXP, which will enable you to successfully face regulatory audits/inspections, and achieve approvals/certifications from agencies such as the FDA (USA), EDQM, EU national authorities, TPD (Canada), TGA (Australia), MCC (South Africa) the WHO, etc.

PharmAlliance provides assistance and expert advice for preparing regulatory submissions for any of the countries/regions listed in our Country/Service Matrix, ranging from the multi-billion dollar markets of USA, Canada, Europe and Australia, South Africa, to the rapidly growing markets of Asia and Latin America. We provide complete inputs to ensure generation of the relevant regulatory data (CMC as well as preclinical, clinical or bioequivalence data) for preparation of regulatory submissions in the CTD, eCTD, or alternative (national) formats,

We specialize in ensuring crystal clear documentation that will result in a faster, smoother, more cost-efficient approval process from start to finish. Typical examples of the submissions that we can prepare and handle are listed below.


TYPES OF SUBMISSIONS :

Click the hyperlinks for details....

USA & CANADA	EUROPE	OTHER
Drug Master Files (DMFs)	European Drug Master Files (EDMFs)	TGA Registrations
IND, NDA/NDS, BLAs, ANDA/ANDS, Supplementals	EDQM Certificates of Suitability (CEP / COS)	MCC Registrations
510(K) Applications / Market Notifications	Full or Abridged National, Mutual Recognition, and Centralized MAAs (including UK)	WHO GMP Certification
NDC Applications / DIN Applications	Medical Device Filings / CE Mark	Other Certifications / Registrations / Approvals
PRODUCT SUBMISSIONS IN CTD, eCTD, OR ALTERNATIVE (NATIONAL) FORMATS