GLOBAL REGULATORY SERVICES INCLUDE
FDAc is comprised of senior regulatory & GMP experts with extensive experience in pharmaceutical excipients and preparation of global registration strategies with different regulatory authorities worldwide.
FDA related services
FDAc offers FDA-related services to clients, such as document preparation/reviews, audits and reviews, compliance problem resolution, training, regulatory affairs strategic assistance, preparation and/or review of regulatory filings and other specialized services.
Documents for QA & QC
FDAc provides clients with quality assurance and control documentation, such as evaluation of written procedures and standard operating procedures, development of laboratory systems and specification, corporate oversight programs and more.
Quality audit guidance
FDAc completes due diligence audits to support strategic mergers and acquisitions.
System and process validation & qualification
FDAc offers system and process validation or qualification documents including programmatic assistance, computer system validation, and specific validation/qualification documents.
Scientific and technical assistance
FDAc provides clients scientific and technical assistance to resolve complex problems including a review program for data integrity as well as other significant scientific and technical challenges.
DMF filing
FDAc is all set to support US DMF (Type 4) filing for all types of pharmaceutical excipients.
System evaluation
FDAc offers systems evaluation services such as R&D and manufacturing systems assessment as well as review and recommendations for quality control/quality assurance systems.
Training
Our team of experienced and updated scientific and technical persons is always available to train your technical personnel to achieve self-confidence and a grip on the regulatory compliance worldwide besides problem solving in your functional areas.
Providing assistance for various certifications
The experience and exposure clubbed with the updated knowledge and information of our group is ready to provide necessary assistance for upgrading and updating your systems to meet the needs of specific regulatory bodies across the globe.
Dealing in instruments/equipment specialized disposable items and disinfectant products
Apart from the products we offer, we are always ready to offer you our expertise for selection and source of right instruments and equipment for your laboratory and manufacturing needs.
Our Key services
- Pharmaceutical excipients and nutraceuticals
- G(x)P compliance services [GMP, GLP, GCP, GDP, due diligence, Validation, CSV, Data integrity etc.]
- Audits and pre-audit inspection as per country-specific requirements
- Regulatory compilation of all modules CTD-M1, M2, M3, M4, M5 and Global submissions (eCTD). In addition to above technical, GMP validation documentation support as per USFDA, EMA, TGA, and other country-specific requirements
- Dossier writing from module 1 to Module 5 (NDA & ANDA)
- US-DMF Type IV file review and writing
- Query response - preparation of query response based on health authority’s query and timely submission to our client/ authority (including CAPA preparation)
- In-house training and workshops for RA, QA, GMP, ICH, IPEC, validations and related areas
FDAc offers a full portfolio of capabilities to deliver measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by the Food & Drug Administration.
