> Submission Component Preparation
> Scanning services and legacy document conversion
> Document and report publishing
> Structured product labeling conversion services
> Clinical Data Interchange Standards Consortium (CDISC) and U.S. Food and Drug Administration (FDA) submission data conversion services
> Global Submission Publishing
> Paper submission publishing
> Electronic common technical document (eCTD) submission planning and tracking
> Electronic submission publishing, including eCTD and non-eCTD electronic submission and hybrid formats
> Conversion of paper/legacy format to eCTD format applications
> Staff augmentation
> Consulting
> Regional regulatory consultation
> Defining eCTD granularity
> Submission readiness assessment, including eCTD readiness review and gap analysis
> Training and Education
> Introduction to electronic submissions and authoring for eCTD submissions
> Submission and document lifecycle processes and concepts
> Considerations for report and case report form publishing
> Publishing clinical study reports for paper and electronic submissions

AGENCY MEETING

Arranging meeting schedule with Health Authority for technical discussion.

QUERY RESPONSE

Preparation of query response based on Health Authority’s query and timely submission to our client / authority

MARKETING AUTHORIZATION HOLDER

A market authorization holder (MAH) is a company, firm or nonprofit organization which has obtained market authorization through market authorization application (MAA) for marketing of specific medicinal product.

LEGAL REPRESENTATIVE

A legal representative is a person who has to be informed about the investigational study which is supposed to be conducted on human subject as per the ethical committees approval

We have a staff comprising of PhDs and M. Pharms for managing medical and Pharma related project

We work as a vital link between the regulatory agency and our customers to deliver most upto date and quality customer service. We helps to ensure the quality and safety of our customer products and to make it available to the patients in need as early as possible.

Comprehensive audits as per GMP auditing requirements, ISO, UK-MHRA, MCC, TGA, in house or other standards as required by the client organization

Auditing of

> API / Excipient / Packaging materials Vendor
> Analytical and stability centers
> Formulation and manufacturing sites
> Clinical and preclinical study centers

National

> CTAs, IMPDs, INDs, NDAs, MAA, global registration submissions.
> DMFs.
> EDQM Certificate of Suitability applications.
> Territory-specific site registration applications.

International

Scientific advice procedures (EMEA or national authorities)

Preparing briefing packages and participating at authority meetings, EMEA, FDA etc.

Clinical trial applications (CTAs)

Review of data, Gap Analyses and preparation of dossiers and applications for required countries. Development and review of investigational medicinal product dossiers (IMPDs)

Mandatory provision of Legal Representative for clinical trials

When a clinical study sponsor does not have a local country office we accept to take the Legal Representative role in the countries that require it e.g. EU, Australia

Orphan drug designations (ODDs)

Creation and submission of ODD applications

Pediatric Investigation Plans (PIP)

Writing, submission and negotiation of PIPs for EU approval process

Marketing authorization approval dossiers (MAAs)

Writing of complete dossiers or specific parts.

European CTD overviews and CTD summaries

CTD summaries and overviews for various elements of dossier such as clinical, non-clinical and chemistry/pharmacy using expertise from external sources if required during the process

Support with product safety data evaluation and compilation of Risk Management Plans (RMP) Pre-approval sales authorizations

Experience of regulatory processes for compassionate/named patient use for niche products, orphan drugs and other special situations

National

> Complete life cycle management service
> Supporting license maintenance (variations, renewals, annual reports, PBRER/ PSURs).
> Safety, manufacturing and CMC activities
> Linguistic Review including labelling and artworks.
> In-country support.
> Regulatory intelligence.
> Site rationalization regulatory support.
> Compliance gap analysis.
> Stability data assessments.
> CTD conversions (content and format).

International

Maintenance of licenses, marketing authorization variations

Changes in manufacturing, Product labeling etc.

Acting as local Marketing Authorization Holder (MAH)

Support for products in transition of ownership ensuring smooth marketing authorization while during processes such as partnering

Availability of Qualified Personnel (QP)

For various processes such as for batch release, site audits etc.

Provision of Qualified staff for Pharmacovigilance (QPPV)

Provision of Scientific / Medical service

Pharmacmissions

FDA, Eudora Vigilance and other territory submissions, SUSARs, PSURs / PBRERs and DSURs including medical review

Management of special regulatory requirements

Response to EU Article 31 procedures, product recalls etc.