We cater the following requirements

A dossier is a comprehensive document submitted to drug regulatory bodies for registering a product. It usually comprises different parts or modules reflecting complete information on the Active Pharmaceutical Ingredient and finished formulation, from its very birth to market withdrawal.

Different modules contain information on Administrative, Chemistry and Manufacturing Control (CMC), Non-Clinical and Clinical parts, with a diverse granularity of essential documents depicting quality, safety and efficacy.

Once a product is registered, add-on documents are submitted during the product lifecycle — post-approval changes, variations and periodic safety reports (PSUR, PADER, PBRER). A quality dossier, complete in all respects, shortens the approval process and is directly proportionate to revenue generation.

• Registration dossier preparation, compilation and review (CTD, ACTD, region-specific guidelines)
• Filing to domestic as well as international regulatory bodies
• Post-approval changes, variations and renewals

Pharmacovigilance is the branch of pharmacology dealing with product safety across the entire lifecycle. PV departments work closely with national pharmacovigilance authorities, continuously during clinical trials (Drug Safety Update Reports) and in market (Periodic Safety Update Reports), gathering information from healthcare professionals, marketing teams, patients and literature reviews.

Regpace assists you in achieving the necessary tools for smooth functioning of the pharmacovigilance department.

• Pharmacovigilance system setup
• Pharmacovigilance call centre setup
• End-to-end case processing
• Risk management plans
• Literature review
• Signal detection and management
• Company Core Data Sheet (CCDS) update
• SmPC (Summary of Product Characteristics) update
• Aggregate report writing — PSURs, PBRERs, PADERs

The Central Drugs Standard Control Organization is the Indian drug regulatory body under the Ministry of Health, Government of India. Indian pharmaceutical regulatory operations are distributed between state and centre: state bodies are responsible for manufacturing and distribution, while the centre, through the Drug Controller General of India, lays down standards for new drugs, clinical trials and import-related activities.

Drugs

• Investigational New Drug (IND), New Drug Approval (NDA), Subsequent New Drug (SND) and Fixed Dose Combinations (FDC)
• Bioequivalence / clinical trial strategy planning
• Association with CDSCO and EU/US approved centres for BE and clinical trial conduct
• Medical writing for non-clinical and clinical summary reports
• Bioequivalence NOC (BE-NOC) for export
• Test licence, Export NOC, Free Sale Certificate
• Wholesale licence, Import licence, Shelf life extension

Medical devices

• Manufacturing new medical device (Form 29, 44, 46)
• Manufacturing notified medical device (Form 27, 28)
• Manufacturing non-notified medical device (Form 27, 28)
• Registration Certificate (Form 41)
• Import licence (Form 8, 10)

Cosmetics

• Manufacturing (Form 32)
• Manufacturing on loan licence (Form 32A)
• Form 37
• Registration Certificate (Form 43)

Biologicals

• Manufacturing biologicals (Form 44, 46)
• Form 29
• Test licence

Exporters often need to attest, apostille or legalise a variety of documents for shipping consignments — Good Manufacturing Practice certificates (GMP), Certificate of Pharmaceutical Product (COPP), Certificate of Origin (COO), Power of Attorney and related documents. These attestations assure the importer of the originality of the documents. Regpace assists you in attesting these from the Chamber of Commerce, Ministry of External Affairs or embassies in a time-efficient manner.

Attestation

• The Ministry of External Affairs (MEA), Government of India is responsible for attestation and issuing the Apostille stamp
• MEA outsourced its attestation and apostille services to a number of vendors from 1 March 2012
• All original documents to be legalised require authentication from the issuing authority
• Educational documents attested by the Human Resource Department of the concerned state
• Non-educational documents attested by the concerned state department with stamp and designation of the responsible officer
• Commercial documents attested by the Chamber of Commerce of the respective state

Apostille

• The MEA apostille service complies with the Hague Convention of October 1961, enabling apostilled documents to be accepted across member countries
• Same document authentication chain applies: issuing authority, state department or Chamber of Commerce, then MEA

Regpace offers a comprehensive solution for all your pharma designs. Whether it is artwork designing for planned products or visual aids, you will be surprised by the quality we offer at sustainable prices.

• Artwork design
• Booth designing for exhibitions
• Visual aids
• Catch covers
• Leave Behind Cards (LBC)
• Posters, boxes and labels
• Stationery
• Websites and web promotion
• Promotional gifts and conference design

Exporting companies often need to translate documents into a number of languages for a variety of commercial needs. Whether you need a single package insert or a whole dossier translated, we assist you in achieving the best translation. We are associated with world-class medical translators efficient in medical terminology.

• Guidelines translation
• Package insert translation
• Dossier translation
• Artwork translation
• Translation for attestation
• General document translation

Sugam is the online portal developed by C-DAC, Department of Electronics and Information Technology, Government of India, for streamlining and speeding up the regulatory system. Launched on 14 November 2015, this portal has changed the regulatory process in India. We assist you in the technical understanding of, and submissions through, the Sugam portal.